[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test preparation dapagliflozin metformin extended-release tablets (Ⅰ) (specification: 10 mg/1000 mg) and the reference preparation Anda-Sol® (specification: 10 mg/1000 mg) in healthy adult subjects under fasting and fed 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达格列净二甲双胍缓释片(Ⅰ)(规格:10 mg/1000 mg,山东百诺医药股份有限公司提供、复星医药(徐州)有限公司生产)与参比制剂达格列净二甲双胍缓释片(Ⅰ)(安达释®,规格:10 mg/1000 mg,AstraZeneca AB持证、AstraZeneca Pharmaceuticals LP生产)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下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂达格列净二甲双胍缓释片(Ⅰ)(规格:10 mg/1000 mg)和参比制剂达格列净二甲双胍缓释片(Ⅰ)(安达释®,规格:10 mg/1000 mg)在健康成年受试者中的安全性。
[Translation] Main study objectives: To study the pharmacokinetics of the test preparation dapagliflozin metformin extended-release tablets (I) (Specification: 10 mg/1000 mg, provided by Shandong Baino Pharmaceutical Co., Ltd. and produced by Fosun Pharmaceutical (Xuzhou) Co., Ltd.) and the reference preparation dapagliflozin metformin extended-release tablets (I) (Anda-Rel®, Specification: 10 mg/1000 mg, licensed by AstraZeneca AB and produced by AstraZeneca Pharmaceuticals LP) in healthy adult subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations in fasting and fed state.
Secondary study objectives: To evaluate the safety of the test preparation dapagliflozin metformin extended-release tablets (I) (Specification: 10 mg/1000 mg) and the reference preparation dapagliflozin metformin extended-release tablets (I) (Anda-Rel®, Specification: 10 mg/1000 mg) in healthy adult subjects.