[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study was conducted to evaluate the bioequivalence of the test preparation, dapagliflozin metformin extended-release tablets (I) (strength: 10 mg/1000 mg) and the reference preparation, dapagliflozin metformin extended-release tablets (I) (Xigduo® XR, strength: 10 mg/1000 mg) in healthy adult subjects in the fasting and fed state.
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,重庆博腾药业有限公司生产)与参比制剂达格列净二甲双胍缓释片(Ⅰ)(Xigduo® XR,规格:10 mg/1000 mg,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)(Xigduo® XR,规格:10 mg/1000 mg)在健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation dapagliflozin metformin extended-release tablets (I) (specification: 10 mg/1000 mg, produced by Chongqing Boteng Pharmaceutical Co., Ltd.) and the reference preparation dapagliflozin metformin extended-release tablets (I) (Xigduo® XR, specification: 10 mg/1000 mg, produced by AstraZeneca Pharmaceuticals LP) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study is 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) (Xigduo® XR, specification: 10 mg/1000 mg) in healthy adult subjects.