[Translation] A single-center, randomized, open-label, single-dose, two-sequence, two-cycle, crossover bioequivalence trial of dapoxetine hydrochloride tablets in Chinese healthy adult male subjects under fasting and postprandial conditions
主要目的:健康成年男性受试者在空腹和餐后状态下单剂量口服盐酸达泊西汀片受试制剂与参比制剂后,以药代动力学参数为终点评价指标,评价武汉九珑人福药业有限责任公司提供的盐酸达泊西汀片(规格:60mg)是否与Menarini-Von Heyden GmbH生产的盐酸达泊西汀片(持证商:Berlin-Chemie AG,商品名:必利劲®,规格:60mg)具有生物等效性。
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(商品名:必利劲®)在健康成年男性受试者中的安全性。
[Translation] Main purpose: After oral administration of a single dose of dapoxetine hydrochloride tablets test preparation and reference preparation to healthy adult male subjects in fasting and postprandial states, pharmacokinetic parameters were used as end-point evaluation indicators to evaluate the efficacy of Wuhan Jiulong people. Is the dapoxetine hydrochloride tablets (specification: 60 mg) provided by Fu Pharmaceutical Co., Ltd. consistent with the dapoxetine hydrochloride tablets produced by Menarini-Von Heyden GmbH (licensee: Berlin-Chemie AG, trade name: Priligin ®, strength: 60mg) is bioequivalent.
Secondary purpose: To observe the safety of the test preparation dapoxetine hydrochloride tablets and the reference preparation dapoxetine hydrochloride tablets (trade name: Priligy®) in healthy adult male subjects.