[Translation] A randomized, open-label, single-dose, two-formulation, two-period, crossover design bioequivalence study of metformin hydrochloride tablets in healthy volunteers under fasting and fed conditions
健康受试者在空腹或餐后状态下口服北京中惠药业有限公司生产的受试制剂盐酸二甲双胍片与Merck Santé S.A.S生产的参比制剂盐酸二甲双胍片(商品名:Glucophage®)后,评价受试制剂与参比制剂是否具有生物等效性。观察受试制剂与参比制剂在健康受试者中的安全性。
[Translation] After healthy subjects orally took the test preparation metformin hydrochloride tablets produced by Beijing Zhonghui Pharmaceutical Co., Ltd. and the reference preparation metformin hydrochloride tablets (trade name: Glucophage®) produced by Merck Santé S.A.S. on an empty stomach or after a meal, the bioequivalence of the test preparation and the reference preparation was evaluated. The safety of the test preparation and the reference preparation in healthy subjects was observed.