Bioequivalence of metformin hydrochloride tablets in Chinese healthy volunteers

Objective To evaluate the bioequivalence of two domestic metformin hydrochloride tablets in healthy volunteers.MethodsA single oral dose(1.0 g of test and reference formulation) was given to 20 healthy volunteers in a randomized crossover study.The concentrations of metformin hydrochloride in plasma were determined by HPLC.The bioavailability and bioequivalence of two formulations were evaluated by DAS 2.0 software,then the bioequivalence was judged.ResultsAfter a single dose,the pharmacokinetic parameters for tested and reference metformin hydrochloride were as follows: Cmax were(2.83±0.53),(2.57±0.57) mg·L-1;Tmax were(1.55±0.39),(1.63±0.36)h;t1/2 were(3.70±1.76),(3.36±0.72)h;AUC0-24 were(10.20±1.95),(9.71± 2.56) mg·h·L-1,respectively.The 90%confidential interval of AUC0-24,AUC0-∞ and Cmax of test formulation were 99.1%-114.6%,99.1%-113.8% and 100.6%-110.4%,respectively.The relative bioavailability of test to reference formulation was(108.3±20.5)%.ConclusionThe test and reference metformin hydrochloride were bioequivalence.