[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 formulation, tadalafil tablets (strength: 20 mg), and the reference formulation, Cialis® (strength: 20 mg), in healthy adult participants in the fasting and fed states.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂他达拉非片(规格:20 mg,湖北同德堂药业有限公司生产)与参比制剂他达拉非片(希爱力®,规格:20 mg,Lilly del Caribe, Inc.生产)在健康参与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:评估受试制剂他达拉非片(规格:20 mg)和参比制剂他达拉非片(希爱力®,规格:20 mg)在健康参与者中的安全性。
[Translation] Primary study objective: To study the pharmacokinetics of a single oral dose of the test preparation tadalafil tablets (20 mg, produced by Hubei Tongdetang Pharmaceutical Co., Ltd.) and the reference preparation tadalafil tablets (Cialis®, 20 mg, produced by Lilly del Caribe, Inc.) in healthy participants in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary study objective: To evaluate the safety of the test preparation tadalafil tablets (20 mg) and the reference preparation tadalafil tablets (Cialis®, 20 mg) in healthy participants.