OBJECTIVE To determine the
relative bioavailability of
compound metformin hydrochloride tablets in healthy volunteers.METHODS A single dose of compound
Metformin Hydrochloride tablets(0.5 g metformin
Hydrochloride and 2.5 mg
glibenclamide) or
Metformin hydrochloride tablets(0.5 g) and glibenclamide(2.5 mg) were given to 18 healthy volunteers in a randomized crossover study.An HPLC-UV method for the determination of metformin hydrochloride and an HPLC/MS method for the determination of glibenclamide in plasma were established and the pharmacokinetic parameters of metformin hydrochloride and glibenclamide were obtained,and then the bioavailability and bioequivalence were evaluated.RESULTS After the drug administration to the 18 healthy volunteers,the
AUC_(0～24),AUC_(0→∞),C_(max),t_(max) for metformin hydrochloride were(6 252.9±2 628.3)and(6 270.6±2 202.6)ng·h·mL~(-1),(6 764.4±2 895.2)and(7 195.1±4 153.1)(ng·h·mL~(-1)),(1 082.4±3 48.2)and(1 111.0±343.3)ng·mL~(-1),(1.5±0.5)and(1.7±0.6)h respectively.The relative bioavailability of compound metformin hydrochloride tablets to metformin hydrochloride tablets was 99.72%±13.59%.The AUC_(0～36h),AUC_(0→∞) C_(max),and t_(max) for glibenclamide were(533.5±247.0)and(495.7±223.3)ng·h·mL~(-1 ),(578.8±263.8)and(525.4±253.5)ng·h·mL~(-1) ,(94.1±19.1)and(87.39±20.72)ng·mL~(-1),(1.8±0.4)and(1.9±0.4)h respectively.The relative bioavailability of compound metformin hydrochloride tablets to hydrochloride tablets was 103.83%±12.94%.CONCLUSIONS There were no significant differences between compound metformin hydrochloride tablets and the co-administration of metformin hydrochloride tablets and glibenclamide,and bioequivalence was observed.
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