[Translation] Randomized, open, single administration, two preparations, two-period crossover design, evaluating the test preparation Metformin Hydrochloride Tablets (Chongqing Yaoyou Pharmaceutical Co., Ltd.) and the reference preparation Metformin Hydrochloride Tablets (trade name: Glycoran) (NIPPON SHINYAKU CO.,LTD., NIPPON SHINYAKU CO., LTD.) bioequivalence test in Chinese healthy subjects.
主要目的:以重庆药友制药有限责任公司生产,重庆吉斯瑞制药有限责任公司持证的盐酸二甲双胍片为受试制剂,以 NIPPON SHINYAKU CO.,LTD.(日本新薬株式会社)生产的盐酸二甲双胍片(商品名:Glycoran)为参比制剂,进行生物等效性试验,评价受试制剂和参比制剂是否生物等效。
次要目的:考察中国健康成年受试者空腹/餐后状态下口服试验药物的安全性。
[Translation] Main purpose: Metformin hydrochloride tablets produced by Chongqing Yaoyou Pharmaceutical Co., Ltd. and licensed by Chongqing Jisirui Pharmaceutical Co., Ltd. as the test preparation, and metformin hydrochloride produced by NIPPON SHINYAKU CO., LTD. The tablet (trade name: Glycoran) is used as the reference preparation, and the bioequivalence test is carried out to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary purpose: To investigate the safety of oral administration of the test drug in Chinese healthy adult subjects in the fasting/fed state.