[Translation] A single-center, randomized, open-label, single (fasting/after meal) oral administration, two preparations, two sequences, two cycles, crossover human bioequivalence study of metformin glibenclamide tablets in Chinese healthy subjects test
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] Main purpose: To observe the single oral administration of the test preparation Metformin Glibenclamide Tablets (specification: 500mg/2.5mg) and the reference preparation Metformin Glyburide Tablets (trade name: Glucovance®; Specification: 500mg/2.5mg; Licensee: Merck SANTE S.A.S) to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary purpose: To observe the safety of the test preparation metformin glyburide tablets and the reference preparation metformin glyburide tablets (Glucovance®) in Chinese healthy subjects.