[Translation] A single-center, randomized, open-label, fasting and fed single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of dapagliflozin and metformin extended-release tablets in healthy adult Chinese subjects.
主要研究目的:
考察单次单剂量口服(空腹/餐后)受试制剂达格列净二甲双胍缓释片(规格:10mg/1000mg,北京伟林恒昌医药科技有限公司委托北京京丰制药集团有限公司生产)与参比制剂达格列净二甲双胍缓释片(Xigduo XR,规格:10mg/1000mg,AstraZeneca Phanuaceuticals LP 生产),在成年健康受试者的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价空腹、餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the relative bioavailability of single-dose oral (fasting/postprandial) test preparation dapagliflozin metformin extended-release tablets (specification: 10mg/1000mg, produced by Beijing Weilin Hengchang Pharmaceutical Technology Co., Ltd. and Beijing Jingfeng Pharmaceutical Group Co., Ltd.) and reference preparation dapagliflozin metformin extended-release tablets (Xigduo XR, specification: 10mg/1000mg, produced by AstraZeneca Phanuaceuticals LP) in healthy adult subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug.
Secondary study objectives:
To evaluate the safety of single oral fasting and postprandial test preparations and reference preparations in healthy adult Chinese subjects.