[Translation] A single-center, open-label, randomized, single-dose, two-formulation, two-period, two-sequence, crossover human bioequivalence study of oral metformin hydrochloride extended-release tablets in healthy subjects under fasting and fed conditions
主要目的:以哈尔滨同一堂药业有限公司生产及提供的盐酸二甲双胍缓释片(规格:0.5g)为受试制剂,按有关生物等效性试验的规定,与默克制药(江苏)有限公司生产的盐酸二甲双胍缓释片【商品名】格华止®(Glucophage®XR)(规格:0.5g)为参比制剂,进行生物等效性试验。
次要目的:观察受试制剂盐酸二甲双胍缓释片(规格:0.5g)与参比制剂盐酸二甲双胍缓释片【商品名】格华止®(Glucophage®XR)(规格:0.5g)在健康人群中的安全性。
[Translation] Main purpose: To conduct bioequivalence test with metformin hydrochloride sustained-release tablets (specification: 0.5g) produced and provided by Harbin Tongyitang Pharmaceutical Co., Ltd. as the test preparation and metformin hydrochloride sustained-release tablets (trade name) Glucophage®XR (specification: 0.5g) produced by Merck Pharmaceuticals (Jiangsu) Co., Ltd. as the reference preparation according to the relevant provisions of bioequivalence test.
Secondary purpose: To observe the safety of the test preparation metformin hydrochloride sustained-release tablets (specification: 0.5g) and the reference preparation metformin hydrochloride sustained-release tablets (trade name) Glucophage®XR (specification: 0.5g) in healthy people.