Wuhan Wall Biotechnology Co., Ltd.

The aim was to study the pharmacokinetic characteristics of a single fasting intramuscular injection of fosphenytoin sodium injection (10 ml: 0.5 g (calculated as C15H11N2NaO2)) developed by Wuhan Huaer Biotechnology Co., Ltd. and produced by Wuhan Qirui Pharmaceutical Co., Ltd. in healthy study participants; using Parke Davis's certified fosphenytoin sodium injection (Cerebyx®, 50 mg/mL (calculated as C15H11N2NaO2)) as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, to evaluate the human bioequivalence of the two preparations, and to observe the safety of the two preparations in healthy study participants.

Primary objective: To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of dapoxetine hydrochloride tablets (specification: 30 mg, applicant: Wuhan Huaer Biotechnology Co., Ltd.) and the reference formulation (trade name: Priligy®, specification: 30 mg, licensee: Berlin-Chemie AG) in healthy Chinese adult male subjects after oral administration under fasting and postprandial conditions. Secondary objective: To study the safety of the test formulation dapoxetine hydrochloride tablets (specification: 30 mg) and the reference formulation dapoxetine hydrochloride tablets (Priligy®) (specification: 30 mg) in healthy adult male subjects.