[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of empagliflozin metformin extended-release tablets (25 mg/1000 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 Pharmaceuticals,Inc持证,Patheon Pharmaceuticals Inc.生产的恩格列净二甲双胍缓释片(商品名:Synjardy® XR,规格:25mg/1000mg)为参比制剂,对重庆博腾药业有限公司提供的受试制剂恩格列净二甲双胍缓释片(规格:25mg/1000mg)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二甲双胍缓释片(规格:25mg/1000mg)和参比制剂恩格列净二甲双胍缓释片(商品名:Synjardy® XR,规格:25mg/1000mg)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, the empagliflozin metformin sustained-release tablets (trade name: Synjardy® XR, specification: 25mg/1000mg) produced by Patheon Pharmaceuticals Inc. and licensed by Boehringer Ingelheim Pharmaceuticals, Inc. were selected as the reference preparation, and the test preparation empagliflozin metformin sustained-release tablets (specification: 25mg/1000mg) provided by Chongqing Boteng Pharmaceutical Co., Ltd. were subjected to human bioequivalence test for 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 study objective: To observe the safety of oral administration of the test preparation empagliflozin metformin sustained-release tablets (specification: 25mg/1000mg) and the reference preparation empagliflozin metformin sustained-release tablets (trade name: Synjardy® XR, specification: 25mg/1000mg) to healthy volunteers.