[Translation] A randomized, open, single-dose, two-formulation, two-sequence, two-period, self-crossover controlled study was conducted to evaluate the bioequivalence of dapoxetine hydrochloride tablets in Chinese healthy subjects after a single oral administration in the fasting and postprandial states.
主要目的:以浙江北生药业汉生制药有限公司提供的盐酸达泊西汀片(规格:30mg(按C21H23NO计))为受试制剂,按生物等效性试验的有关规定,与Berlin-Chemie AG持证的盐酸达泊西汀片(商品名:必利劲®/Priligy®,规格:30mg(按C21H23NO计),参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂盐酸达泊西汀片和参比制剂盐酸达泊西汀片(必利劲®/Priligy®)在健康受试者中的安全性。
[Translation] Main purpose: Using dapoxetine hydrochloride tablets (specification: 30 mg (calculated as C21H23NO)) provided by Zhejiang Beisheng Pharmaceutical Hansheng Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the absorption rate and degree of dapoxetine hydrochloride tablets (trade name: Priligy®/Priligy®, specification: 30 mg (calculated as C21H23NO), reference preparation) certified by Berlin-Chemie AG were compared in healthy humans, and the human bioequivalence of the two preparations was investigated.
Secondary purpose: To observe the safety of the test preparation dapoxetine hydrochloride tablets and the reference preparation dapoxetine hydrochloride tablets (Priligy®/Priligy®) in healthy subjects.