[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-preparation, two-sequence, two-cycle crossover bioequivalence study of dapoxetine hydrochloride tablets in Chinese adult healthy male subjects.
主要研究目的:
考察单次单剂量口服60 mg(空腹/餐后)受试制剂盐酸达泊西汀片(规格:60 mg,悦康药业集团股份有限公司生产)与参比制剂盐酸达泊西汀片(商品名:Priligy®,规格:60 mg,Menarini-Von Heyden GmbH生产),在中国成年健康男性受试者中的相对生物利用度,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。
次要研究目的:
评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康男性受试者中的安全性。
[Translation] Main research purposes:
Examine a single oral dose of 60 mg (fasting/after meals) of the test preparation Dapoxetine Hydrochloride Tablets (specification: 60 mg, produced by Yuekang Pharmaceutical Group Co., Ltd.) and the reference preparation Dapoxetine Hydrochloride Tablets ( Trade name: Priligy®, strength: 60 mg, produced by Menarini-Von Heyden GmbH), the relative bioavailability in Chinese adult healthy male subjects, the pharmacokinetic parameters of the two preparations were analyzed, and the bioavailability of the two preparations was evaluated. Equivalence.
Secondary research purpose:
To evaluate the safety of the test preparation and reference preparation after a single oral administration on an empty stomach or after a meal in Chinese adult healthy male subjects.