[Translation] Single dose of metformin hydrochloride tablets (0.25 g) produced by Dandong Yichuang Pharmaceutical Co., Ltd. and metformin hydrochloride tablets (trade name: Glycoran, 0.25 g) licensed by NIPPON SHINYAKU CO., LTD. in healthy subjects Bioequivalence study in drug, randomized, open-label, two-cycle, double-crossover, fasting and postprandial states
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] Main research purposes: Take metformin hydrochloride tablets (trade name: Glycoran) certified by NIPPON SHINYAKU CO., LTD. as the reference preparation, and metformin hydrochloride tablets produced by Dandong Yichuang Pharmaceutical Co., Ltd. as the test preparation. A central, randomized, open-label, single-dose, two-cycle, double-crossover clinical study was conducted to evaluate the human bioequivalence of the two formulations.
Secondary research objectives: To observe the safety of the test preparation and reference preparation in healthy Chinese subjects.