[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of empagliflozin tablets (25 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择Boehringer Ingelheim International GmbH为持证商的恩格列净片(商品名:Jardiance;规格:25mg)为参比制剂,对云鹏医药集团有限公司生产并提供的受试制剂恩格列净片(规格:25mg)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。
次要研究目的:观察健康志愿受试者口服受试制剂恩格列净片(规格:25mg)和参比制剂恩格列净片(商品名:Jardiance;规格:25mg)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, empagliflozin tablets (trade name: Jardiance; specification: 25mg) with Boehringer Ingelheim International GmbH as the licensee were selected as the reference preparation, and the test preparation empagliflozin tablets (specification: 25mg) produced and provided by Yunpeng Pharmaceutical Group Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of oral administration of the test preparation empagliflozin tablets (specification: 25mg) and the reference preparation empagliflozin tablets (trade name: Jardiance; specification: 25mg) by healthy volunteers.