[Translation] A single-center, randomized, open-label, two-sequence, two-period, crossover bioequivalence study of dapagliflozin tablets in the postprandial state in healthy Chinese population
主要研究目的:考察单次单剂量口服(餐后)受试制剂达格列净片(规格:10mg,惠升生物制股份药有限公司申办)与参比制剂达格列净片(安达唐®,规格:10mg,AstraZenecaPharmaceuticalsLP生产),在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。 次要研究目的:评价餐后单次口服受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to investigate the relative bioavailability of the single-dose oral (postprandial) test preparation dapagliflozin tablets (specification: 10 mg, applied for by Huisheng Biopharmaceutical Co., Ltd.) and the reference preparation dapagliflozin tablets (Andatang®, specification: 10 mg, produced by AstraZeneca Pharmaceuticals LP) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation after a single oral administration in healthy Chinese subjects.