[Translation] A single-center, randomized, open-label, two-period, two-dose, two-sequence, crossover bioequivalence study of tadalafil tablets 20 mg in healthy Chinese subjects after single oral administration on an empty stomach or after a meal
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 study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of tadalafil tablets (specification: 20 mg, holder: Hunan Jiaheng Pharmaceutical Co., Ltd.) and the reference formulation Cialis® (specification: 20 mg, licensee: Eli Lilly Nederland B.V.) after a single oral dose in healthy Chinese male subjects under fasting and postprandial conditions.
Secondary study objectives
To study the safety of the test formulation of tadalafil tablets (specification: 20 mg) and the reference formulation Cialis® (specification: 20 mg) in healthy subjects.