[Translation] A randomized, open-label, two-period, double-crossover, fasting pharmacokinetic study of vildagliptin, empagliflozin, and metformin extended-release tablets in healthy Chinese subjects.
主要目的:以越洋医药开发(广州)有限公司研制的维格列汀恩格列净二甲双胍缓释片(规格:100mg/10mg/500mg)为受试制剂,以Novartis Europharm Ltd.生产的维格列汀片(商品名:佳维乐,规格:50mg)为对照制剂1,Boehringer Ingelheim International GmbH生产的恩格列净片(商品名:欧唐静,规格:10mg)为对照制剂2,Merck Serono Limited生产的盐酸二甲双胍缓释片(商品名:格华止,规格:500mg)为对照制剂3,比较空腹状态下口服受试制剂与对照制剂1、2、3在中国健康受试者体内的血药浓度及主要药代动力学参数(AUC、Cmax、tmax、t1/2等),评价受试制剂与对照制剂1、2、3的AUC等效情况以及PK特征比对。
次要目的:评价中国健康受试者空腹状态下口服受试制剂和对照制剂1、2、3后的安全性和耐受性。
[Translation] Main objective: Using vildagliptin-empagliflozin-metformin extended-release tablets (100mg/10mg/500mg) developed by Yueyang Pharmaceutical Development (Guangzhou) Co., Ltd. as the test formulation, vildagliptin tablets (trade name: Jiaweile, strength: 50mg) manufactured by Novartis Europharm Ltd. as control formulation 1, empagliflozin tablets (trade name: Otangjing, strength: 10mg) manufactured by Boehringer Ingelheim International GmbH as control formulation 2, and metformin hydrochloride extended-release tablets (trade name: Glucophage, strength: 500mg) manufactured by Merck Serono Limited as control formulation 3, this study compared the plasma drug concentrations and major pharmacokinetic parameters (AUC, Cmax, tmax, t1/2, etc.) of the test formulation and control formulations 1, 2, and 3 in healthy Chinese subjects under fasting oral administration. The study also evaluated the AUC equivalence and pharmacokinetic characteristics of the test formulation and control formulations 1, 2, and 3.
Secondary objective: To evaluate the safety and tolerability of oral administration of the test formulation and control formulations 1, 2, and 3 to healthy Chinese subjects in a fasting state.