[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of metformin hydrochloride tablets (0.25 g) produced by Dandong Yichuang Pharmaceutical Co., Ltd. and metformin hydrochloride tablets (trade name: Glycoran, 0.25 g) certified by NIPPON SHINYAKU CO., LTD. in healthy subjects under fasting and fed conditions
主要研究目的:以NIPPON SHINYAKU CO.,LTD.持证的盐酸二甲双胍片(商品名:Glycoran)为参比制剂,以丹东医创药业有限责任公司生产的盐酸二甲双胍片为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the metformin hydrochloride tablets (trade name: Glycoran) certified by NIPPON SHINYAKU CO., LTD. as the reference preparation and the metformin hydrochloride tablets produced by Dandong Yichuang Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in humans through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.