[Translation] A single-center, single-dose, fasting/after-meal medication, 2 preparations, 2 cycles, 2 sequences, open, randomized, crossover bioequivalence study of Darpagliflozin Tablets in healthy subjects.
在健康受试者体内,分别在空腹、餐后状态下,以AstraZeneca AB持有的达格列净片(商品名:安达唐(FORXIGA);规格:10 mg)为参比制剂,研究福元药业有限公司研制的达格列净片(受试制剂;规格:10 mg)的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] In the body of healthy subjects, under fasting and postprandial conditions respectively, taking Dapagliflozin Tablets held by AstraZeneca AB (trade name: FORXIGA; specification: 10 mg) as the reference preparation, study Fuyuan Pharmaceutical The absorption speed and degree of Dapagliflozin Tablets (test preparation; specification: 10 mg) developed by Dapagliflozin Industry Co., Ltd. were evaluated to evaluate whether the test preparation and the reference preparation had bioequivalence. To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.