[Translation] A randomized, open-label, single-dose, two-preparation, two-sequence, two-cycle, double-crossover design bioequivalence trial of a single oral dose of metformin empagliflozin tablets (Ⅰ) in healthy subjects under fasting and postprandial conditions
主要研究目的: 研究空腹和餐后状态下单次口服受试制剂二甲双胍恩格列净片(Ⅰ)(规格:每片含盐酸二甲双胍500mg与恩格列净5mg,河南福森药业有限公司生产,嘉亨(珠海横琴)医药科技有限公司提供)与参比制剂二甲双胍恩格列净片(Synjardy®,规格:5mg;500mg,Boehringer Ingelheim Pharma GmbH&Co.KG生产,Boehringer Ingelheim Pharmaceuticals Inc持证)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的: 空腹和餐后状态下,研究单次口服受试制剂二甲双胍恩格列净片(Ⅰ)和参比制剂二甲双胍恩格列净片(Synjardy®)在健康成年受试者中的安全性。
[Translation] Main research purpose: To study the single oral administration of the test preparation Metformin Empagliflozin Tablets (Ⅰ) in the fasting and postprandial state (Specifications: Each tablet contains 500 mg of metformin hydrochloride and 5 mg of empagliflozin, produced by Henan Fusen Pharmaceutical Co., Ltd. Provided by Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.) and the reference preparation metformin empagliflozin tablets (Synjardy®, specification: 5mg; 500mg, produced by Boehringer Ingelheim Pharma GmbH&Co.KG, licensed by Boehringer Ingelheim Pharmaceuticals Inc) in health Pharmacokinetics in adult subjects to evaluate the bioequivalence of two oral formulations in the fasting and postprandial states.
Secondary study purpose: To study the effects of a single oral dose of the test formulation Metformin Empagliflozin Tablets (Ⅰ) and the reference formulation Metformin Empagliflozin Tablets (Synjardy®) in healthy adult subjects under fasting and postprandial conditions. safety.