[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, two-sequence, two-period, crossover-design bioequivalence study was conducted in healthy male subjects in China. The study was conducted on dapoxetine hydrochloride tablets (30 mg) produced by Guangdong Saifeng Pharmaceutical Technology Co., Ltd. and dapoxetine hydrochloride tablets (trade name: Priligy, 30 mg) marketed by Berlin-Chemie AG.
考察受试制剂和参比制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性;并评价盐酸达泊西汀片在健康受试者中的安全性。
[Translation] To investigate the pharmacokinetic parameters and relative bioavailability of the test preparation and the reference preparation after single administration in the fasting and postprandial states, to evaluate whether the two preparations are bioequivalent; and to evaluate the safety of dapoxetine hydrochloride tablets in healthy subjects.