[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of dapagliflozin metformin extended-release tablets (Ⅰ) (10 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AstraZeneca AB为持证商的达格列净二甲双胍缓释片(Ⅰ)(商品名:Xigduo XR(安达释®),规格:10mg/1000mg)为参比制剂,对石家庄龙泽制药股份有限公司生产、河北智恒医药科技股份有限公司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:Xigduo XR(安达释®),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: Xigduo XR (Anda Shi®), 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 by Shijiazhuang Longze Pharmaceutical Co., Ltd. and provided by Hebei Zhiheng Pharmaceutical Technology Co., Ltd. was subjected to fasting and fed human bioequivalence test, 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 fed 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: Xigduo XR (Anda Shi®), specification: 10 mg/1000 mg) to healthy subjects.