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Abstract
\n\nBackground: As WHO expresses, coronavirus disease 2019 (COVID-19) is the infectious disease caused by the most recently discovered
\n\ncoronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. COVID-
\n\n19 is now a pandemic affecting many countries globally. Antiviral agents play fundamental role in Covid-19 treatment. Favipiravir is
\n\none of the favored agents and it still draws attention of generic drug industry which is constitutional for drug accessibility.
\n\nObjective: The aim of this study is to demonstrate the bioequivalence of a new Favipiravir tablet formulation as compared to the
\n\nreference tablet formulation in healthy male subjects under fasting conditions.To prove the bioequivalence, a randomised, single oral
\n\ndose, cross-over, two-period study was carried out in 30 healthy subjects under fasting conditions. Plasma Favipiravir levels were
\n\nquantified by using an in-house-developed high performance Liquid Chromatography Coupled to Tandem Mass Spectrometry (LCMS/
\n\nMS) method.
\n\nResults: The 90% CIs for the test/reference geometric mean ratios of the Cmax and AUC0-tlast were 92.92 – 119.89% and 94.00 –
\n\n99.77%, respectively.
\n\nConclusions: This single-dose study has shown that the test and reference Favipiravir products met the required bioequivalence
\n\ncriteria. Besides, both products were well tolerated and safe.
", "publication_date": "2020-12-17", "publisher": "Zenodo", "resource_type": { "id": "publication-article", "title": { "de": "Zeitschriftenartikel", "en": "Journal article" } }, "rights": [ { "description": { "en": "The Creative Commons Attribution license allows re-distribution and re-use of a licensed work on the condition that the creator is appropriately credited." }, "icon": "cc-by-icon", "id": "cc-by-4.0", "props": { "scheme": "spdx", "url": "https://creativecommons.org/licenses/by/4.0/legalcode" }, "title": { "en": "Creative Commons Attribution 4.0 International" } } ], "subjects": [ { "subject": "Key Words: Favipiravir; Bioequivalence; Covid-19" } ], "title": "Single Dose, Two-way Crossover Bioequivalence Study of Favipiravir Tablet in Healthy Male Subjects" }, "parent": { "access": { "owned_by": { "user": 75111 } }, "communities": {}, "id": "4361816", "pids": { "doi": { "client": "datacite", "identifier": "10.5281/zenodo.4361816", "provider": "datacite" } } }, "pids": { "doi": { "client": "datacite", "identifier": "10.5281/zenodo.4361817", "provider": "datacite" }, "oai": { "identifier": "oai:zenodo.org:4361817", "provider": "oai" } }, "revision_id": 2, "stats": { "all_versions": { "data_volume": 71151744.0, "downloads": 128, "unique_downloads": 126, "unique_views": 234, "views": 250 }, "this_version": { "data_volume": 70039998.0, "downloads": 126, "unique_downloads": 124, "unique_views": 223, "views": 239 } }, "status": "published", "updated": "2020-12-19T12:27:12.455672+00:00", "versions": { "index": 1, "is_latest": true } }