Bioequivalence Study of Two IR Metformin Formulations: an Open-Label, Randomised, Two Treatments, Two-Way Crossover Study in Healthy Volunteers

Abstract

Pharmacokinetic properties of two immediate-release formulations of Metformin 250mg were studied in 24 healthy male volunteers under fasting condition. Volunteers were given either the test or reference formulation randomly at first study interval, and crossed over at second study interval. Non-compartmental model was used to analyse the pharmacokinetic parametres. Results had shown no significant difference between two formulations in terms of maximum plasma concentration and the time to reach such maximum concentration (Cmax and Tmax ). The half-life (T1/2) and the elimination rate constant (Ke ) were found to be comparable. There was no statistical significant difference for the area-under-the-curve (AUC) as well. No adverse event was reported. In conclusion, the test formulation was bioequivalent with the reference formulation.