[Translation] To evaluate the single-center, open-label, randomised, single-center, open-label, single-center, open-label, single-center, open-label, randomized controlled trial of the test preparation Tadalafil Tablets (Strength: 20 mg) and the reference preparation Cialis® (Strength: 20 mg) in healthy adult subjects under fasting and postprandial conditions. Dose, two-cycle, two-sequence, crossover bioequivalence studies
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,江苏利泰尔药业有限公司生产)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)在健康受试者中的安全性。
[Translation] Main research purpose: To study the single oral administration of the test preparation Tadalafil Tablets (specification: 20 mg, produced by Jiangsu Litail Pharmaceutical Co., Ltd.) and the reference preparation Tadalafil Tablets (Xiaai Lilly®, strength: 20 mg, manufactured by Lilly del Caribe, Inc.) in healthy subjects to evaluate the bioequivalence of the two oral formulations in the fasting and postprandial states.
Secondary study purpose: To evaluate the safety of the test preparation Tadalafil Tablets (strength: 20 mg) and the reference preparation Tadalafil Tablets (Cialis®, strength: 20 mg) in healthy subjects.