/ Not yet recruitingNot Applicable 恩格列净片(10mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of empagliflozin tablets (10 mg) in Chinese healthy subjects under fasting and fed conditions
按有关生物等效性试验的规定,选择Boehringer Ingelheim International GmbH持证的恩格列净片(商品名:Jardiance(欧唐静®);规格:10mg)为参比制剂,对合肥立方制药股份有限公司生产,合肥康惠医药技术有限公司提供的受试制剂恩格列净片(规格:10mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
[Translation] In accordance with the relevant provisions of bioequivalence tests, empagliflozin tablets (trade name: Jardiance®; specification: 10 mg) certified by Boehringer Ingelheim International GmbH were selected as the reference preparation, and the test preparation empagliflozin tablets (specification: 10 mg) produced by Hefei Cube Pharmaceutical Co., Ltd. and provided by Hefei Kanghui Pharmaceutical Technology Co., Ltd. were subjected to human bioequivalence tests on fasting and fed administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under fasting and fed administration conditions was evaluated.
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