Bioequivalence study of metformin hydrochloride in healthy adult human subjects under fed condition”

Author : Ashwin singh chouhan

Keyword : Bioequivalence; pharmacokinetics; metformin; type ii diabetes mellitus

Subject : Pharmacology

Article Type : Original article (research)

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Abstract : Background: - Type-2 diabetes mellitus is a common metabolic disorder, where metformin is used as the first-line treatment. Since metformin absorption is altered when administered with food, the US FDA guidance on metformin hydrochloride recommended to conduct bioequivalence study in both fasting and fed conditions. In this study, we intended to establish bioequivalence between a locally manufactured metformin formulation with a reference formulation under fed condition. Methods: - Pharmacokinetics of randomized, open-label, four-treatment, four-period, four-sequence, single-dose, four- way crossover study in 24 healthy volunteers. The washout period was 7 days to allow adequate time for drug elimination from the body. Analysis of plasma metformin concentration was conducted with a validated reverse-phase HPLC with ultraviolet detection procedure. Non-compartmental modal was used to analyse the pharmacokinetic parameters. Tolerability of both formulations was assessed throughout the study. Results: - Twenty four (24) healthy, adult, male human subjects were included in the study. A total of Nineteen (19) subjects completed all the four periods of the study. Based on the statistical results of the 90% confidence intervals of the geometric mean ratios from Ln-transformed parameters data Cmax, AUC0-t and AUC0-∞ of Metformin hydrochloride, conclusions were drawn whether the test formulation was bioequivalent to the reference formulation under fed condition. Mean Concentration versus time plots (linear and Ln-linear) are presented below for Metformin. Tables summarizing the mean test-to-reference ratios and their associated 90% confidence intervals are also provided for Metformin. Conclusions:-The test metformin 1000 mg formulation was not bioequivalent to the reference formulation.

Article by : ASHWIN SINGH CHOUHAN

Article add date : 2022-07-04

How to cite : Ashwin singh chouhan. (2022-July-04). Bioequivalence study of metformin hydrochloride in healthy adult human subjects under fed condition”. retrieved from https://www.openacessjournal.com/abstract/1090