Human bioequivalence test of Metformin Hydrochloride Tablets under fasting and high-fat diet conditions
Objective To evaluate the bioequivalence,relative bioavailability and safety of a single dose of Metformin Hy-drochloride Tablets in healthy subjects under fasting and high-fat diet conditions.Methods A single-center,single-dose,open-label,randomized,double-crossed,design was conducted.Sixty-five healthy subjects from Yiyang Central Hospital from September to October 2017 were selected as study subjects,32 were enrolled fasting and 33 were enrolled after meals.Plasma concentration of Metformin Hydrochloride Tablets were obtained after 0.25 g drug were administered.The pharmacoki-netic parameters were calculated,and bioequivalence of the two preparations was evaluated.Results Thirty-two subjects were enrolled under fasting condition,the main pharmacokinetic parameters of the test and reference formulations of Met-formin Hydrochloride Tablets were as follows:Cmax were(769.310±164.148)ng/ml and(738.720±127.457)ng/ml,AUC0-t were(4 737.900±920.287)h·ng/ml and(4 647.700±869.177)h·ng/ml,AUC0-∞ were(4 808.330±928.534)h·ng/ml and(4 717.670±875.598)h·ng/ml.Thirty-three subjects were enrolled under fed condition,the main pharmacokinetic parame-ters of the test and reference formulations of Metformin Hydrochloride Tablets were as follows:Cmax were(476.100±99.755)ng/ml and(467.520±94.557)ng/ml,AUC0-t were(3 677.200±770.824)h·ng/ml and(3 673.860±754.462)h·ng/ml,AUC0-∞were(3 762.760±783.383)h·ng/ml and(3 745.280±761.178)h·ng/ml.The main pharmacokinetic parameters were ana-lyzed by logarithmic transformation,90％CI of Cmax,AUC0-t and AUC0-∞ for two drugs the geometric mean ratio were all in area of 80.00％-125.00％.Conclusion The test formulation was bioequivalent to the reference formulation when adminis-tered under fasting and high-fat meal conditions,and the drug was well tolerated and safe.
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