Bioequivalence study of two Esomeprazole40 mg MUPS tablets in healthy adult Bangladeshi human subjects
Authors/Creators
- 1. Department of Quality Assurance, Novus CRSL, Dhaka, Bangladesh.
- 2. Department of Analytical, Novus CRSL, Dhaka, Bangladesh.
- 3. Department of Diagnostic, Novus CRSL, Dhaka, Bangladesh.
- 4. Head of Novus, Novus CRSL, Dhaka, Bangladesh.
- 5. Department of Virology, National Institute of Laboratory Medicine & Referral Centre (NILMRC) and Lab in Charge, Novus CRSL, Dhaka, Bangladesh.
Description
Background: The primary objective of this study is to investigate the bioequivalence of two formulations (test& reference) of Esomeprazole 40 mg MUPS Tablet in healthy, adult human subjects.
Method: In this study, a single dose, two-sequence, two-way crossover randomized design was used to investigate the bioequivalence under fasting conditions. 14 healthy volunteers received the two formulations over the course of two treatment days, each followed by a seven-day washout period. Following the administration of a single dose of 40 mg of each formulation, blood samples were taken at predetermined time points and subjected to a validated LC-MS/MS method for Esomeprazole concentration analysis. The plasma concentration-time profiles of both formulations were used to determine the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞.
Result: Pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ did not show any statistically significant differences. The 90 % confidence intervals of Cmax, AUC0-t, and AUC0-∞ for Esomeprazole was found 89.35% (82.27-97.03%), 107.61% (99.78-116.05%), and 107.72 (99.87-116.20%) respectively which is within predetermined bioequivalence acceptance limits of 80 - 125 %.
Conclusion: In terms of absorption rate and extent, the test product of Beximcopharmaceuticals has met the regulatory requirements for bioequivalence with the reference product Nexium MUPS.