[Translation] A single-center, randomized, open-label, dual-cycle, dual-preparation, dual-sequence, crossover study of tadalafil tablets 20 mg orally administered in a single fasting and postprandial dose in healthy Chinese subjects
bioequivalence test
主要研究目的
评价中国健康男性受试者空腹及餐后条件下单次单剂量口服他达拉非片受试制剂(规格:20 mg,持有人:湖南嘉恒制药有限公司)和参比制剂希爱力®(规格:20 mg,持证商:Eli Lilly Nederland B.V.)后的药代动力学特点和生物等效性。
次要研究目的
研究受试制剂他达拉非片(规格:20 mg)和参比制剂希爱力®(规格:20 mg)在健康受试者中的安全性。
[Translation] Main research purpose
To evaluate the test preparation (specification: 20 mg, holder: Hunan Jiaheng Pharmaceutical Co., Ltd.) and the reference preparation Cialis® in a single oral dose of tadalafil tablets under fasting and postprandial conditions in healthy Chinese male subjects (Strength: 20 mg, Licensee: Eli Lilly Nederland B.V.) Post-Pharmacokinetics and Bioequivalence.
Secondary research purpose
To study the safety of the test preparation tadalafil tablets (strength: 20 mg) and the reference preparation Cialis® (strength: 20 mg) in healthy subjects.