[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial), two-formulation, two-sequence, two-period, crossover bioequivalence study of metformin and glibenclamide tablets in healthy Chinese subjects
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂二甲双胍格列本脲片(规格:500mg/2.5mg)和参比制剂二甲双胍格列本脲片(商品名:Glucovance®;规格:500mg/2.5mg;持证商:Merck SANTE S.A.S)后的药代动力学特征,评价两种制剂在空腹/餐后状态下的生物等效性。
次要目的:观察受试制剂二甲双胍格列本脲片和参比制剂二甲双胍格列本脲片(Glucovance®)在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation metformin glibenclamide tablets (specification: 500mg/2.5mg) and the reference preparation metformin glibenclamide tablets (trade name: Glucovance®; specification: 500mg/2.5mg; licensee: Merck SANTE S.A.S) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary objective: To observe the safety of the test preparation metformin glibenclamide tablets and the reference preparation metformin glibenclamide tablets (Glucovance®) in healthy Chinese subjects.