[Translation] A single-center, randomized, open-label, fasting and fed, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of tadalafil tablets in healthy adult Chinese subjects
主要研究目的:
考察单次口服(空腹/餐后)受试制剂他达拉非片(规格:20 mg,海南赛立克药业有限公司生产,海南斯达制药有限公司提供)与参比制剂他达拉非片(CIALIS®,规格:20 mg,Lilly del Caribe.Inc.持证)在中国健康人体(仅男性)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,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价受试制剂和参比制剂单次口服(空腹/餐后)在中国成年健康受试者(仅男性)中的安全性。
[Translation] Main study objectives:
To investigate the relative bioavailability of the test preparation tadalafil tablets (specification: 20 mg, produced by Hainan Celic Pharmaceutical Co., Ltd. and provided by Hainan Star Pharmaceutical Co., Ltd.) and the reference preparation tadalafil tablets (CIALIS®, specification: 20 mg, licensed by Lilly del Caribe. Inc.) in healthy Chinese subjects (males only) after a single oral administration (fasting/after meals), analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug.
Secondary study objectives:
To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects (males only) after a single oral administration (fasting/after meals).