[Translation] A single-center, randomized, open-label, two-preparation, four-cycle, two-sequence, single-dose, fully replicated crossover bioequivalence study of vardenafil hydrochloride tablets in Chinese healthy subjects under fasting and postprandial conditions
主要目的:以伐地那非的主要药代动力学参数(AUC和Cmax)为生物等效性评价指标,在中国健康受试者空腹和餐后状态下评估受试制剂(杭州民生药物研究院有限公司委托江苏万高药业股份有限公司生产的盐酸伐地那非片,规格:20mg)和参比制剂(Bayer AG持证的盐酸伐地那非片,规格:20mg;商品名:Levitra®)的生物等效性。
次要目的:观察空腹和餐后状态下受试制剂和参比制剂的安全性。
[Translation] Main purpose: Use the main pharmacokinetic parameters of vardenafil (AUC and Cmax) as bioequivalence evaluation indicators to evaluate the test preparations in Chinese healthy subjects under fasting and postprandial conditions (Hangzhou Minsheng Pharmaceutical Research Institute The company entrusted Jiangsu Wangao Pharmaceutical Co., Ltd. to produce vardenafil hydrochloride tablets, specification: 20mg) and reference preparations (Bayer AG licensed vardenafil hydrochloride tablets, specification: 20mg; trade name: Levitra® ) bioequivalence.
Secondary purpose: To observe the safety of the test preparation and reference preparation under fasting and postprandial conditions.