[Translation] A single-dose, randomized, open-label, two-period, two-sequence, crossover bioequivalence study of metformin hydrochloride extended-release tablets in healthy subjects under fasting and fed conditions
主要研究目的
研究空腹和餐后状态下单次口服受试制剂盐酸二甲双胍缓释片(规格:0.5g,以岭万洲国际制药有限公司生产)与参比制剂盐酸二甲双胍缓释片(商品名:格华止®,规格:0.5g,默克制药(江苏)有限公司生产)在健康成年受试者体内的药代动力学,评价两制剂生物等效性。
次要研究目的
评价健康受试者空腹和餐后单次口服受试制剂盐酸二甲双胍缓释片和参比制剂盐酸二甲双胍缓释片(格华止®)后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation metformin hydrochloride sustained-release tablets (specification: 0.5g, produced by Yiling Wanzhou International Pharmaceutical Co., Ltd.) and the reference preparation metformin hydrochloride sustained-release tablets (trade name: Glucophage®, specification: 0.5g, produced by Merck Pharmaceuticals (Jiangsu) Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting and postprandial state, and to evaluate the bioequivalence of the two preparations.
Secondary study objectives
To evaluate the safety of the test preparation metformin hydrochloride sustained-release tablets and the reference preparation metformin hydrochloride sustained-release tablets (Glucophage®) after a single oral administration in healthy subjects after fasting and postprandial state.