[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover, fasting and fed bioequivalence study of dapagliflozin tablets in healthy Chinese subjects
主要研究目的
本试验以四川新斯顿制药股份有限公司生产的达格列净片(规格:10mg)为受试制剂,以AstraZeneca Pharmaceuticals LP生产的达格列净片(商品名:安达唐/FORXIGA,规格∶10mg)为参比制剂,分别考察空腹和餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。
次要研究目的
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main study objectives
This study used dapagliflozin tablets (specification: 10 mg) produced by Sichuan Xinston Pharmaceutical Co., Ltd. as the test preparation and dapagliflozin tablets (trade name: Andatang/FORXIGA, specification: 10 mg) produced by AstraZeneca Pharmaceuticals LP as the reference preparation to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects in the fasting and postprandial states, and to evaluate the bioequivalence of the two preparations.
Secondary study objectives
To observe the safety of the test preparation and the reference preparation in healthy subjects.