id,name,overallEffect,isControlData,croCutoff,croIdentifier,comment,experimentalConditionsComment,resultsComment,internalComment,objectCompoundId,objectMetaboliteCompoundId,precipitantCompoundId,cytochromeB5Id,studyId,experimentTypeId,testSystemId,controlDataExperimentId,controlDataForExperimentId,study.id,study.name,study.napdiIdentifier,study.overallSummary,study.pubmedId,study.embaseId,study.croIdentifier,study.croInformation,study.dateStart,study.dateEnd,study.internalComment,study.status,study.naturalProductId,study.studySourceTypeId,study.studySourceType.id,study.studySourceType.name,study.naturalProduct.id,study.naturalProduct.name,study.naturalProduct.itis,study.naturalProduct.conceptId,testSystem.id,testSystem.name,testSystem.sortOrder,testSystem.conceptId,testSystem.categoryId,testSystem.category.id,testSystem.category.name,testSystem.category.sortOrder,testSystem.category.requiresCytochromeB5,cytochromeB5.id,cytochromeB5.name,cytochromeB5.sortOrder,cytochromeB5.conceptId,measurements.id,measurements.isControl,measurements.comparison,measurements.value,measurements.valueString,measurements.precision,measurements.scale,measurements.low,measurements.high,measurements.variability,measurements.numberOfExperiments,measurements.compoundId,measurements.experimentId,measurements.measurementTypeId,measurement.measurementTypeName,measurements.unitId,measurements.valueTypeId,measurements.valueType.id,measurements.valueType.name,measurements.valueType.format,measurements.valueType.conceptId,measurements.unit.id,measurements.unit.name,measurements.unit.conceptId,transporters.id,transporters.name,transporters.conceptId,transporters.experiment_transporter_xref.experimentId,transporters.experiment_transporter_xref.transporterId,enzymes.id,enzymes.name,enzymes.conceptId,enzymes.experiment_enzyme_xref.enzymeId,enzymes.experiment_enzyme_xref.experimentId,objectMetaboliteCompound.id,objectMetaboliteCompound.name,objectMetaboliteCompound.unii,objectMetaboliteCompound.inChIKey,objectMetaboliteCompound.publicDescription,objectMetaboliteCompound.internalComment,objectMetaboliteCompound.conceptId,objectMetaboliteCompound.enantiomerOfId,precipitantCompound.id,precipitantCompound.name,precipitantCompound.unii,precipitantCompound.inChIKey,precipitantCompound.publicDescription,precipitantCompound.internalComment,precipitantCompound.conceptId,precipitantCompound.enantiomerOfId,objectCompound.id,objectCompound.name,objectCompound.unii,objectCompound.inChIKey,objectCompound.publicDescription,objectCompound.internalComment,objectCompound.conceptId,objectCompound.enantiomerOfId,experimentType.id,experimentType.name,experimentType.isInVitro,experimentType.isTransporter,experimentType.isEnzyme
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1676,false,=,3,3,1,0,,,,,1,610,119,T<sub>max</sub>,28,2,2,Mean,1,,28,h,8505,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1675,,=,11.1111111111,11.11,4,2,,,,,1,610,112,C<sub>max</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1674,true,=,3.69,3.69,3,2,,,,,1,610,112,C<sub>max</sub>,24,2,2,Mean,1,,24,ng/mL,8842,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1673,false,=,4.1,4.1,2,1,,,,,1,610,112,C<sub>max</sub>,24,2,2,Mean,1,,24,ng/mL,8842,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1672,,=,111.8421052632,111.84,5,2,,,,,1,610,102,AUC<sub>(0-infinity)</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1671,true,=,15.2,15.2,3,1,,,,,1,610,102,AUC<sub>(0-infinity)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1670,false,=,32.2,32.2,3,1,,,,,1,610,102,AUC<sub>(0-infinity)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1669,,=,66.6666666667,66.67,4,2,,,,,1,610,104,AUC<sub>(0-t)</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1668,true,=,14.1,14.1,3,1,,,,,1,610,104,AUC<sub>(0-t)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1667,false,=,23.5,23.5,3,1,,,,,1,610,104,AUC<sub>(0-t)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1666,,=,-9.2184368737,-9.22,4,2,,,,,26,610,117,Half-life (terminal),1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1665,true,=,4.99,4.99,3,2,,,,,26,610,117,Half-life (terminal),28,2,2,Mean,1,,28,h,8505,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1664,,=,100,100,5,2,,,,,26,610,119,T<sub>max</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1663,true,=,0.5,0.5,1,1,,,,,26,610,119,T<sub>max</sub>,28,2,2,Mean,1,,28,h,8505,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1662,,=,-18.2352941176,-18.24,5,2,,,,,26,610,112,C<sub>max</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1661,true,=,10.2,10.2,3,1,,,,,26,610,112,C<sub>max</sub>,24,2,2,Mean,1,,24,ng/mL,8842,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1660,,=,6.5743944637,6.57,3,2,,,,,26,610,111,CL/F,1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1659,true,=,57.8,57.8,3,1,,,,,26,610,111,CL/F,25,2,2,Mean,1,,25,L/h,44777603,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1658,,=,-6.0185185185,-6.02,4,2,,,,,26,610,102,AUC<sub>(0-infinity)</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1657,true,=,43.2,43.2,3,1,,,,,26,610,102,AUC<sub>(0-infinity)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1656,,=,-5.9665871122,-5.97,4,2,,,,,26,610,104,AUC<sub>(0-t)</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1655,true,=,41.9,41.9,3,1,,,,,26,610,104,AUC<sub>(0-t)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1654,false,=,61.6,61.6,3,1,,,,,26,610,111,CL/F,25,2,2,Mean,1,,25,L/h,44777603,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1653,false,=,4.53,4.53,3,2,,,,,26,610,117,Half-life (terminal),28,2,2,Mean,1,,28,h,8505,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1677,true,=,0.5,0.5,1,1,,,,,1,610,119,T<sub>max</sub>,28,2,2,Mean,1,,28,h,8505,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1676,false,=,3,3,1,0,,,,,1,610,119,T<sub>max</sub>,28,2,2,Mean,1,,28,h,8505,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1675,,=,11.1111111111,11.11,4,2,,,,,1,610,112,C<sub>max</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1674,true,=,3.69,3.69,3,2,,,,,1,610,112,C<sub>max</sub>,24,2,2,Mean,1,,24,ng/mL,8842,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1673,false,=,4.1,4.1,2,1,,,,,1,610,112,C<sub>max</sub>,24,2,2,Mean,1,,24,ng/mL,8842,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1672,,=,111.8421052632,111.84,5,2,,,,,1,610,102,AUC<sub>(0-infinity)</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1671,true,=,15.2,15.2,3,1,,,,,1,610,102,AUC<sub>(0-infinity)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1670,false,=,32.2,32.2,3,1,,,,,1,610,102,AUC<sub>(0-infinity)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1669,,=,66.6666666667,66.67,4,2,,,,,1,610,104,AUC<sub>(0-t)</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1668,true,=,14.1,14.1,3,1,,,,,1,610,104,AUC<sub>(0-t)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1667,false,=,23.5,23.5,3,1,,,,,1,610,104,AUC<sub>(0-t)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1666,,=,-9.2184368737,-9.22,4,2,,,,,26,610,117,Half-life (terminal),1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1665,true,=,4.99,4.99,3,2,,,,,26,610,117,Half-life (terminal),28,2,2,Mean,1,,28,h,8505,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1664,,=,100,100,5,2,,,,,26,610,119,T<sub>max</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1663,true,=,0.5,0.5,1,1,,,,,26,610,119,T<sub>max</sub>,28,2,2,Mean,1,,28,h,8505,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1662,,=,-18.2352941176,-18.24,5,2,,,,,26,610,112,C<sub>max</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1661,true,=,10.2,10.2,3,1,,,,,26,610,112,C<sub>max</sub>,24,2,2,Mean,1,,24,ng/mL,8842,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1660,,=,6.5743944637,6.57,3,2,,,,,26,610,111,CL/F,1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1659,true,=,57.8,57.8,3,1,,,,,26,610,111,CL/F,25,2,2,Mean,1,,25,L/h,44777603,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1658,,=,-6.0185185185,-6.02,4,2,,,,,26,610,102,AUC<sub>(0-infinity)</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1657,true,=,43.2,43.2,3,1,,,,,26,610,102,AUC<sub>(0-infinity)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1656,,=,-5.9665871122,-5.97,4,2,,,,,26,610,104,AUC<sub>(0-t)</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1655,true,=,41.9,41.9,3,1,,,,,26,610,104,AUC<sub>(0-t)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1654,false,=,61.6,61.6,3,1,,,,,26,610,111,CL/F,25,2,2,Mean,1,,25,L/h,44777603,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1653,false,=,4.53,4.53,3,2,,,,,26,610,117,Half-life (terminal),28,2,2,Mean,1,,28,h,8505,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1652,false,=,1,1,1,0,,,,,26,610,119,T<sub>max</sub>,28,2,2,Mean,1,,28,h,8505,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1651,false,=,40.6,40.6,3,1,,,,,26,610,102,AUC<sub>(0-infinity)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1650,false,=,39.4,39.4,3,1,,,,,26,610,104,AUC<sub>(0-t)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1648,false,=,8.34,8.34,3,2,,,,,26,610,112,C<sub>max</sub>,24,2,2,Mean,1,,24,ng/mL,8842,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1562,,=,-28.5714285714,-28.57,5,2,,,,,26,610,107,C (plasma),1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1561,false,=,0.5,0.5,1,1,,,,,26,610,107,C (plasma),24,1,1,Single value,1,,24,ng/mL,8842,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1559,true,=,0.7,0.7,1,1,,,,,26,610,107,C (plasma),24,1,1,Single value,1,,24,ng/mL,8842,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1720,false,=,1.12,1.12,3,2,0.929,1.34,,,154,610,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1719,,=,-56.3507109005,-56.35,5,2,,,,,154,610,124,AUC ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1718,true,=,2.11,2.11,3,2,1.65,2.71,,,154,610,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1717,false,=,1.68,1.68,3,2,1.41,2.01,,,1,610,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1716,false,=,0.921,0.921,3,3,0.776,1.09,,,154,610,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1715,false,=,0.922,0.922,3,3,0.778,1.09,,,26,610,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1714,false,=,0.799,0.799,3,3,0.667,0.956,,,26,610,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1714,false,=,0.799,0.799,3,3,0.667,0.956,,,26,610,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1715,false,=,0.922,0.922,3,3,0.778,1.09,,,26,610,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1716,false,=,0.921,0.921,3,3,0.776,1.09,,,154,610,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1717,false,=,1.68,1.68,3,2,1.41,2.01,,,1,610,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1718,true,=,2.11,2.11,3,2,1.65,2.71,,,154,610,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1719,,=,-56.3507109005,-56.35,5,2,,,,,154,610,124,AUC ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1720,false,=,1.12,1.12,3,2,0.929,1.34,,,154,610,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1559,true,=,0.7,0.7,1,1,,,,,26,610,107,C (plasma),24,1,1,Single value,1,,24,ng/mL,8842,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1681,,=,34.6972176759,34.7,4,2,,,,,1,610,117,Half-life (terminal),1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1680,true,=,6.11,6.11,3,2,,,,,1,610,117,Half-life (terminal),28,2,2,Mean,1,,28,h,8505,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1679,false,=,8.23,8.23,3,2,,,,,1,610,117,Half-life (terminal),28,2,2,Mean,1,,28,h,8505,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1678,,=,500,500,5,2,,,,,1,610,119,T<sub>max</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,22,UGT2B7,,22,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1561,false,=,0.5,0.5,1,1,,,,,26,610,107,C (plasma),24,1,1,Single value,1,,24,ng/mL,8842,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1562,,=,-28.5714285714,-28.57,5,2,,,,,26,610,107,C (plasma),1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1648,false,=,8.34,8.34,3,2,,,,,26,610,112,C<sub>max</sub>,24,2,2,Mean,1,,24,ng/mL,8842,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1650,false,=,39.4,39.4,3,1,,,,,26,610,104,AUC<sub>(0-t)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1651,false,=,40.6,40.6,3,1,,,,,26,610,102,AUC<sub>(0-infinity)</sub>,22,2,2,Mean,1,,22,ng/mL*h,,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1652,false,=,1,1,1,0,,,,,26,610,119,T<sub>max</sub>,28,2,2,Mean,1,,28,h,8505,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1681,,=,34.6972176759,34.7,4,2,,,,,1,610,117,Half-life (terminal),1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1680,true,=,6.11,6.11,3,2,,,,,1,610,117,Half-life (terminal),28,2,2,Mean,1,,28,h,8505,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1679,false,=,8.23,8.23,3,2,,,,,1,610,117,Half-life (terminal),28,2,2,Mean,1,,28,h,8505,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1678,,=,500,500,5,2,,,,,1,610,119,T<sub>max</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
610,CBD Effect on Midazolam,0,false,,GWEP17028,"Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in ""Clinical Pharmacology Biopharmaceutics Review(s)""",,C estimated from Fig 8; page 111,,26,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1677,true,=,0.5,0.5,1,1,,,,,1,610,119,T<sub>max</sub>,28,2,2,Mean,1,,28,h,8505,,,,,,13,CYP3A4,4306811,13,610,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,26,midazolam,R60L0SM5BC,DDLIGBOFAVUZHB-UHFFFAOYSA-N,,,708298,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1725,false,=,2.22,2.22,3,2,1.42,3.46,,,201,614,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1723,false,=,2.64,2.64,3,2,1.95,3.58,,,201,614,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1722,false,=,0.997,0.997,3,3,0.834,1.19,,,200,614,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1721,false,=,1.06,1.06,3,2,0.898,1.24,,,200,614,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1734,,=,-5.0476190476,-5.05,4,2,,,,,200,614,126,C<sub>max</sub> ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1733,true,=,1.05,1.05,3,2,0.401,2.74,,,200,614,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1732,,=,6.4257028112,6.43,3,2,,,,,200,614,124,AUC ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1731,true,=,0.996,0.996,3,3,0.652,1.52,,,200,614,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1730,,=,89.7435897436,89.74,4,2,,,,,201,614,126,C<sub>max</sub> ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1729,true,=,1.17,1.17,3,2,0.628,2.17,,,201,614,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1728,,=,164,164,5,2,,,,,201,614,124,AUC ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1727,true,=,1,1,3,2,0.795,1.27,,,201,614,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1725,false,=,2.22,2.22,3,2,1.42,3.46,,,201,614,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1723,false,=,2.64,2.64,3,2,1.95,3.58,,,201,614,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1722,false,=,0.997,0.997,3,3,0.834,1.19,,,200,614,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1721,false,=,1.06,1.06,3,2,0.898,1.24,,,200,614,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1734,,=,-5.0476190476,-5.05,4,2,,,,,200,614,126,C<sub>max</sub> ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1733,true,=,1.05,1.05,3,2,0.401,2.74,,,200,614,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1732,,=,6.4257028112,6.43,3,2,,,,,200,614,124,AUC ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1731,true,=,0.996,0.996,3,3,0.652,1.52,,,200,614,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1730,,=,89.7435897436,89.74,4,2,,,,,201,614,126,C<sub>max</sub> ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1729,true,=,1.17,1.17,3,2,0.628,2.17,,,201,614,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1728,,=,164,164,5,2,,,,,201,614,124,AUC ratio (treatment/control),1,1,1,Single value,1,,1,%,8554,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
614,CBD Effect on clobazam and N-desmethylclobazam,0,false,,GWEP1428,Study GWEP1428 (p 106),,"Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.<br />Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.<br /><br />CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.<br /><br /><span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">Data from page 109</span>",,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1727,true,=,1,1,3,2,0.795,1.27,,,201,614,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,614,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
615,CBD Effect on N-desmethylclobazam Concentrations,1,false,,,"From page 109 of ""Clinical Pharmacology Biopharmaceutics Review""",,From page 109<br /><br />Units for these values are NOT means but are instead a ratio of day 33 values:day 1 values,,201,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1603,false,=,2.64,2.64,3,2,1.95,3.58,,,201,615,101,AUC<sub>Tau</sub>,22,7,7,Mean (90% CI),4,,22,ng/mL*h,,,,,,,9,CYP2C19,4311137,9,615,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,201,N-Desmethylclobazam,,RRTVVRIFVKKTJK-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
615,CBD Effect on N-desmethylclobazam Concentrations,1,false,,,"From page 109 of ""Clinical Pharmacology Biopharmaceutics Review""",,From page 109<br /><br />Units for these values are NOT means but are instead a ratio of day 33 values:day 1 values,,201,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1616,true,=,1,1,3,2,0.795,1.27,,,201,615,101,AUC<sub>Tau</sub>,22,7,7,Mean (90% CI),4,,22,ng/mL*h,,,,,,,9,CYP2C19,4311137,9,615,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,201,N-Desmethylclobazam,,RRTVVRIFVKKTJK-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
615,CBD Effect on N-desmethylclobazam Concentrations,1,false,,,"From page 109 of ""Clinical Pharmacology Biopharmaceutics Review""",,From page 109<br /><br />Units for these values are NOT means but are instead a ratio of day 33 values:day 1 values,,201,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1617,,=,164,164,5,2,,,,,201,615,101,AUC<sub>Tau</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,9,CYP2C19,4311137,9,615,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,201,N-Desmethylclobazam,,RRTVVRIFVKKTJK-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
615,CBD Effect on N-desmethylclobazam Concentrations,1,false,,,"From page 109 of ""Clinical Pharmacology Biopharmaceutics Review""",,From page 109<br /><br />Units for these values are NOT means but are instead a ratio of day 33 values:day 1 values,,201,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1618,true,=,1.17,1.17,3,2,0.628,2.17,,,201,615,112,C<sub>max</sub>,24,7,7,Mean (90% CI),4,,24,ng/mL,8842,,,,,,9,CYP2C19,4311137,9,615,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,201,N-Desmethylclobazam,,RRTVVRIFVKKTJK-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
615,CBD Effect on N-desmethylclobazam Concentrations,1,false,,,"From page 109 of ""Clinical Pharmacology Biopharmaceutics Review""",,From page 109<br /><br />Units for these values are NOT means but are instead a ratio of day 33 values:day 1 values,,201,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1619,false,=,2.22,2.22,3,2,1.42,3.46,,,201,615,112,C<sub>max</sub>,24,7,7,Mean (90% CI),4,,24,ng/mL,8842,,,,,,9,CYP2C19,4311137,9,615,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,201,N-Desmethylclobazam,,RRTVVRIFVKKTJK-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
615,CBD Effect on N-desmethylclobazam Concentrations,1,false,,,"From page 109 of ""Clinical Pharmacology Biopharmaceutics Review""",,From page 109<br /><br />Units for these values are NOT means but are instead a ratio of day 33 values:day 1 values,,201,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1620,,=,89.7435897436,89.74,4,2,,,,,201,615,112,C<sub>max</sub>,1,1,1,Single value,1,,1,%,8554,,,,,,9,CYP2C19,4311137,9,615,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,201,N-Desmethylclobazam,,RRTVVRIFVKKTJK-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
620,CBD Effect on Stiripentol Concentrations,1,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
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</div>",,"When CBD was combined with stiripentol there was a minor increase in Cmax and AUCtau; 1.28 and 1.55-fold, respectively.",,202,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1622,false,=,1.55,1.55,3,2,1.42,1.69,,,202,620,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,9,In Vivo Interaction,false,false,false
620,CBD Effect on Stiripentol Concentrations,1,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
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</div>",,"When CBD was combined with stiripentol there was a minor increase in Cmax and AUCtau; 1.28 and 1.55-fold, respectively.",,202,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1621,false,=,1.28,1.28,3,2,1.08,1.52,,,202,620,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,9,In Vivo Interaction,false,false,false
621,CBD Effect on Valproic Acid Concentrations,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
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</div>",,,,203,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1623,false,=,1.01,1.01,3,2,0.95,1.07,,,203,621,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
621,CBD Effect on Valproic Acid Concentrations,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
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</div>",,,,203,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1624,false,=,0.99,0.99,2,2,0.9,1.09,,,203,621,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
622,Clobazam Effect on CBD,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
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</div>",,,,115,,200,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1625,false,=,1.34,1.34,3,2,0.93,1.95,,,115,622,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
622,Clobazam Effect on CBD,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
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</div>",,,,115,,200,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1626,false,=,1.3,1.3,2,1,1,1.7,,,115,622,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
623,Clobazam Effect on 6-OH-CBD,0,false,,,"<div class=""page"" title=""Page 102"">
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</div>
</div>
</div>",,,,157,,200,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1628,false,=,1.34,1.34,3,2,1.1,1.63,,,157,623,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,157,6α-OH-cannabidiol,,YYLPAYRRVSQJRR-KSZLIROESA-N,,,,,9,In Vivo Interaction,false,false,false
623,Clobazam Effect on 6-OH-CBD,0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,157,,200,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1627,false,=,1.4,1.4,2,1,1.2,1.62,,,157,623,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,157,6α-OH-cannabidiol,,YYLPAYRRVSQJRR-KSZLIROESA-N,,,,,9,In Vivo Interaction,false,false,false
624,Clobazam Effect on 7-COOH-CBD,0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,198,,200,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1630,false,=,1.31,1.31,3,2,1.04,1.64,,,198,624,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,198,7-COOH-CBD,,,,,,,9,In Vivo Interaction,false,false,false
624,Clobazam Effect on 7-COOH-CBD,0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,198,,200,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1629,false,=,1.35,1.35,3,2,1.12,1.63,,,198,624,126,C<sub>max</sub> ratio (treatment/control),100,12,12,Median (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,198,7-COOH-CBD,,,,,,,9,In Vivo Interaction,false,false,false
625,Clobazam Effect on 7-OH-CBD,0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,199,,200,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1631,false,=,1.73,1.73,3,2,1.36,2.2,,,199,625,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,199,7-hydroxycannabidiol,,ZELUXPWDPVXUEI-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
626,"Stiripentol Effect on CBD, 6-OH-CBD, and 7-COOH-CBD",0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,202,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1634,false,=,1.11,1.11,3,2,0.91,1.35,,,157,626,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
626,"Stiripentol Effect on CBD, 6-OH-CBD, and 7-COOH-CBD",0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,202,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1633,false,=,1.03,1.03,3,2,0.94,1.28,,,115,626,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
626,"Stiripentol Effect on CBD, 6-OH-CBD, and 7-COOH-CBD",0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,202,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1632,false,=,1.13,1.13,3,2,0.96,1.33,,,115,626,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
626,"Stiripentol Effect on CBD, 6-OH-CBD, and 7-COOH-CBD",0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,202,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1637,false,=,0.87,0.87,2,2,0.81,0.94,,,198,626,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
626,"Stiripentol Effect on CBD, 6-OH-CBD, and 7-COOH-CBD",0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,202,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1636,false,=,0.87,0.87,2,2,0.8,0.96,,,198,626,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
626,"Stiripentol Effect on CBD, 6-OH-CBD, and 7-COOH-CBD",0,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,202,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1635,false,=,1.07,1.07,3,2,0.89,1.28,,,157,626,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
627,Stiripentol Effect on 7-OH-CBD,-1,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,199,,202,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1683,false,=,0.72,0.72,2,2,0.61,0.85,,,199,627,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,199,7-hydroxycannabidiol,,ZELUXPWDPVXUEI-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
627,Stiripentol Effect on 7-OH-CBD,-1,false,,,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,199,,202,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1638,false,=,0.71,0.71,2,2,0.51,0.99,,,199,627,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,202,stiripentol,,IBLNKMRFIPWSOY-FNORWQNLSA-N,,,,,199,7-hydroxycannabidiol,,ZELUXPWDPVXUEI-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
628,Valproic Acid Effect on CBD,-1,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study <span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">GWEP1543</span></p>
</div>
</div>
</div>",,,,115,,203,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1684,false,=,1.05,1.05,3,2,0.9,1.78,,,115,628,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
628,Valproic Acid Effect on CBD,-1,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study <span style=""display: inline !important; float: none; background-color: transparent; color: #000000; cursor: text; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 14px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;"">GWEP1543</span></p>
</div>
</div>
</div>",,,,115,,203,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1640,false,=,0.74,0.74,2,2,0.58,0.93,,,115,628,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
629,Valproic Acid Effect on Cannabidiol Metabolites,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,203,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1647,false,=,1.22,1.22,3,2,0.96,1.55,,,198,629,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
629,Valproic Acid Effect on Cannabidiol Metabolites,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,203,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1643,false,=,1.27,1.27,3,2,0.9,1.78,,,157,629,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
629,Valproic Acid Effect on Cannabidiol Metabolites,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,203,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1642,false,=,1.01,1.01,3,2,0.71,1.42,,,157,629,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
629,Valproic Acid Effect on Cannabidiol Metabolites,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,203,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1645,false,=,1.22,1.22,3,2,0.96,1.55,,,199,629,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
629,Valproic Acid Effect on Cannabidiol Metabolites,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,203,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1646,false,=,1.25,1.25,3,2,1.07,1.45,,,198,629,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
629,Valproic Acid Effect on Cannabidiol Metabolites,0,false,,GWEP1543,"<div class=""page"" title=""Page 102"">
<div class=""layoutArea"">
<div class=""column"">
<p>Study GWEP1543</p>
</div>
</div>
</div>",,,,115,,203,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1644,false,=,0.97,0.97,2,2,0.67,1.41,,,199,629,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,,,,,,,,,,,,,,203,valproic acid,,NIJJYAXOARWZEE-UHFFFAOYSA-N,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,9,In Vivo Interaction,false,false,false
631,CBD effect on CLB and N-desmethylclobazam,1,false,,GWEP1543,Study GWEP1543,,Clobazam exposure was increased slightly (~20%) by co-administration with CBD while exposure to the n-desmethylclobazam metabolite was increased by 3.4 fold as a result of concommitant CBD.,,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1688,false,=,1.21,1.21,3,2,1.05,1.39,,,200,631,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,631,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
631,CBD effect on CLB and N-desmethylclobazam,1,false,,GWEP1543,Study GWEP1543,,Clobazam exposure was increased slightly (~20%) by co-administration with CBD while exposure to the n-desmethylclobazam metabolite was increased by 3.4 fold as a result of concommitant CBD.,,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1686,false,=,3.39,3.39,3,2,2.61,4.39,,,201,631,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,631,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
631,CBD effect on CLB and N-desmethylclobazam,1,false,,GWEP1543,Study GWEP1543,,Clobazam exposure was increased slightly (~20%) by co-administration with CBD while exposure to the n-desmethylclobazam metabolite was increased by 3.4 fold as a result of concommitant CBD.,,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1685,false,=,1.2,1.2,3,2,1.05,1.38,,,200,631,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,631,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
631,CBD effect on CLB and N-desmethylclobazam,1,false,,GWEP1543,Study GWEP1543,,Clobazam exposure was increased slightly (~20%) by co-administration with CBD while exposure to the n-desmethylclobazam metabolite was increased by 3.4 fold as a result of concommitant CBD.,,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1688,false,=,1.21,1.21,3,2,1.05,1.39,,,200,631,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,631,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
631,CBD effect on CLB and N-desmethylclobazam,1,false,,GWEP1543,Study GWEP1543,,Clobazam exposure was increased slightly (~20%) by co-administration with CBD while exposure to the n-desmethylclobazam metabolite was increased by 3.4 fold as a result of concommitant CBD.,,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1687,false,=,3.38,3.38,3,2,2.62,4.36,,,201,631,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,631,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
631,CBD effect on CLB and N-desmethylclobazam,1,false,,GWEP1543,Study GWEP1543,,Clobazam exposure was increased slightly (~20%) by co-administration with CBD while exposure to the n-desmethylclobazam metabolite was increased by 3.4 fold as a result of concommitant CBD.,,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1685,false,=,1.2,1.2,3,2,1.05,1.38,,,200,631,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,631,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
631,CBD effect on CLB and N-desmethylclobazam,1,false,,GWEP1543,Study GWEP1543,,Clobazam exposure was increased slightly (~20%) by co-administration with CBD while exposure to the n-desmethylclobazam metabolite was increased by 3.4 fold as a result of concommitant CBD.,,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1686,false,=,3.39,3.39,3,2,2.61,4.39,,,201,631,126,C<sub>max</sub> ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,13,CYP3A4,4306811,13,631,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false
631,CBD effect on CLB and N-desmethylclobazam,1,false,,GWEP1543,Study GWEP1543,,Clobazam exposure was increased slightly (~20%) by co-administration with CBD while exposure to the n-desmethylclobazam metabolite was increased by 3.4 fold as a result of concommitant CBD.,,200,,115,,131,9,,,,131,Drug Approval Package: Epidiolex (Cannabidiol),FDA: 210365 Orig 1,U.S. Food and Drug Administration<br />https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm,,,GW Research Ltd.,GW Research Ltd.,,,,published,5,1,1,Published report,5,Cannabis L.,19108,,,,,,,,,,,,,,,1687,false,=,3.38,3.38,3,2,2.62,4.36,,,201,631,124,AUC ratio (treatment/control),100,7,7,Mean (90% CI),4,,100,,,,,,,,9,CYP2C19,4311137,9,631,,,,,,,,,115,cannabidiol,,QHMBSVQNZZTUGM-ZWKOTPCHSA-N,,,,,200,clobazam,,CXOXHMZGEKVPMT-UHFFFAOYSA-N,,,,,9,In Vivo Interaction,false,false,false