Abstract
Bioavailability and Bioequivalence studies have become an important part of the clinical research in India. This study was performed to find out the safety and efficacy of two Metformin 500 mg tablet (SR formulations). This study was an open label, balanced, randomized, two treatment, two periods, two sequences, single dose, cross over bioequivalence study under fasting condition. Metformin Hydrochloride (SR) 500 mg tablet was the Test formulation and Dibeta SR tablet [containing Metformin Hydrochloride (SR) 500 mg] was the Reference standard. Volunteers were randomly given a single oral dose of the test and the reference formulation under fasting condition, with a washout period of 07 days. Drug concentration in the plasma samples were quantified by using a validated method on LC/MS/MS. Win Nonlin Version 5.2 software was used for statistical calculations. Cmax, AUC0-t and AUC0-∞ values of the test formulation and reference standard were 89.13%, 87.46%, 88.29%, and 112.44%, 123.85% and 123.87%, respectively. Cmax, AUC0-t and AUC0- ∞ values of the test formulation and reference standard fall within the acceptable range of 80–125%. So, the present study concludes that the test formulation is bioequivalent to the reference standard.
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