[Translation] A single-center, randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-sequence, two-period crossover bioequivalence study of torasemide tablets in healthy adult Chinese subjects
主要研究目的: 考察空腹及餐后单次单剂量口服受试制剂托拉塞米片(规格:10mg)与参比制剂托拉塞米片(商品名:Unat®,规格:10mg),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。 次要研究目的: 考察空腹及餐后单次单剂量口服受试制剂和参比制剂在中国成年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 test preparation torsemide tablets (specification: 10 mg) and the reference preparation torsemide tablets (trade name: Unat®, specification: 10 mg) in healthy Chinese subjects after a single oral dose on an empty stomach or after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. The secondary purpose of the study is to investigate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects after a single oral dose on an empty stomach or after a meal.