Journal of Bioequivalence & Bioavailability

Mhatre M

Publications

• Research Article
  Bioequivalence and Pharmacokinetic Comparison of Two Metformin Immediate-release Formulations in Healthy Volunteers under Fed Conditions
  Author(s): Menon S, Kandari K, Mhatre M and Nair SMenon S, Kandari K, Mhatre M and Nair S
  
  Background: Type-2 diabetes mellitus is a common metabolic disorder in Malaysia, 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: The study was a single-dose, open label, randomised, two treatments, two periods, cross-over 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 p.. View More»
  DOI: 10.4172/jbb.1000236

  Abstract PDF