[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of dapagliflozin and metformin extended-release tablets (I) 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AstraZeneca AB为持证商的达格列净二甲双胍缓释片(Ⅰ)(商品名:安达释®(XIGDUO XR®),规格:10mg/1000mg)为参比制剂,对浙江四维医药科技有限公司生产并提供的受试制剂达格列净二甲双胍缓释片(Ⅰ)(规格:10mg/1000mg)进行空腹和餐后给药条件下的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:观察健康受试者口服受试制剂达格列净二甲双胍缓释片(Ⅰ)(规格:10mg/1000mg)和参比制剂达格列净二甲双胍缓释片(Ⅰ)(商品名:安达释®(XIGDUO XR®),规格:10mg/1000mg)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, dapagliflozin metformin sustained-release tablets (Ⅰ) (trade name: Anda Shi® (XIGDUO XR®), specification: 10mg/1000mg) with AstraZeneca AB as the licensee was selected as the reference preparation, and the test preparation dapagliflozin metformin sustained-release tablets (Ⅰ) (specification: 10mg/1000mg) produced and provided by Zhejiang Siwei Pharmaceutical Technology Co., Ltd. was subjected to human bioequivalence test under fasting and postprandial administration conditions, 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 dapagliflozin metformin sustained-release tablets (I) (specification: 10 mg/1000 mg) and the reference preparation dapagliflozin metformin sustained-release tablets (I) (trade name: Anda-release® (XIGDUO XR®), specification: 10 mg/1000 mg) to healthy subjects.