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Bioequivalence and Pharmacokinetics of Metformin Hydrochloride 1000 mg Tablet Extended Formulation in Healthy Indian Male Volunteers

Author: M. Tamilselvi, A. Srinivas

Category: Original research

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This study was to compare the bioavailability and pharmacokinetic properties of test product of Metformin hydrochloride extended release formulation of 1000 mg tablet with reference product of Metformin Hydrochloride (Glucophage®) extended release formulation of 1000 mg in Indian healthy male volunteers. Study design is an open-label, randomized, 2-treatment, single-dose, crossover, bioavailability study to compare test product with reference product in 24 healthy human male volunteers under fed condition. A single oral dose of 1000 mg Metformin (XR) extended release test product, with reference product Metformin Hydrochloride (Glycophage®) extended release was administered as per computer generated randomization schedule during 2 period of the study having 7 days of washout period. A liquid Chromatography mass spectroscopy method was developed and validated as per FDA guideline requirements using Atenolol as an internal standard for the determination of Metformin in human plasma. A non-compartmental pharmacokinetic method was employed to determine the pharmacokinetic parameters (Cmax, Tmax, AUC0-t , AUC0-? and t½) of Metformin using Kinetica (version 4.4.1) software. Cmax, AUC0-t and AUC0-? were used to test for bioequivalence after log transformation of Metformin plasma concentration data. The required Bioequivalence acceptance criteria as per regulatory is 90% CI for bioequivalence study and the range is 0.80 to 1.25. The 90% confidence intervals for log transformed data for Cmax, AUC0-t and AUC0-? for test A vs. reference were 83.18-.95.64, 88.06-104.99 and 94.76-121.59 respectively.

Keywords: Metformin, Bioequivalence, Pharmacokinetics, LC-MS/MS

DOI: 2 June 2014)

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