[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of avanafil tablets under fasting and fed conditions
主要研究目的:以持证商为Menarini International Operations Luxembourg S.A.,由Menarini-Von Heyden GmbH公司生产的阿伐那非片(商品名为Spedra,规格100mg)为参比制剂。以江苏聚荣制药集团有限公司提供的阿伐那非片(规格:100mg)为受试制剂,采用随机、开放、单剂量、两周期双交叉设计,评价两制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要研究目的:评价口服受试制剂阿伐那非片(规格:100mg)和参比制剂(商品名:Spedra、规格:100mg)在中国健康受试者中的安全性。
[Translation] The main purpose of the study: Avanafil tablets (trade name Spedra, specification 100 mg) produced by Menarini-Von Heyden GmbH, with the licensee being Menarini International Operations Luxembourg S.A., were used as the reference preparation. Avanafil tablets (specification: 100 mg) provided by Jiangsu Jurong Pharmaceutical Group Co., Ltd. were used as the test preparation. A randomized, open, single-dose, two-period double crossover design was used to evaluate the bioequivalence of the two preparations in fasting and postprandial states in healthy Chinese subjects.
Secondary purpose of the study: To evaluate the safety of the oral test preparation avanafil tablets (specification: 100 mg) and the reference preparation (trade name: Spedra, specification: 100 mg) in healthy Chinese subjects.