Chengdu Hengrui Pharmaceutical Co. Ltd.

A single-center, randomized, open-label, two-period, self-crossover, single-dose administration design was used to conduct a fasting and fed administration trial to evaluate the bioequivalence and safety of dapoxetine hydrochloride tablets (dapoxetine hydrochloride, specification: 30 mg (calculated as C21H23NO)) produced by Chengdu Hengrui Pharmaceutical Co., Ltd. and dapoxetine hydrochloride tablets (dapoxetine hydrochloride, trade name: Priligy®, specification: 30 mg (calculated as C21H23NO)) certified by Berlin-Chemie AG and produced by Menarini-Von Heyden GmbH after oral administration of the two preparations in healthy Chinese male subjects in the fasting and fed state, so as to provide a basis for the registration application of the test preparation.

Main purpose: 1. To study the pharmacokinetic behavior of sildenafil in healthy male subjects in China after a single oral administration of the test preparation of sildenafil citrate tablets (specification: 50 mg, Chengdu Hengrui Pharmaceutical Co., Ltd.) and the reference preparation of sildenafil citrate tablets (specification: 50 mg, Pfizer Pharmaceutical Co., Ltd.) on an empty stomach, to compare the differences in the pharmacokinetic behavior of the test preparation and the reference preparation, and to preliminarily evaluate the bioequivalence of the test preparation (T) and the reference preparation (R), to provide a reference basis for the rationality of the blood collection time point and sample size design of the formal test. 2. To study the pharmacokinetic behavior of sildenafil in healthy male subjects in China after a single oral administration of the test preparation of sildenafil citrate tablets (specification: 50 mg, Chengdu Hengrui Pharmaceutical Co., Ltd.) and the reference preparation of sildenafil citrate tablets (specification: 50 mg, Pfizer Pharmaceutical Co., Ltd.), to compare the differences in the pharmacokinetic behavior of the test preparation and the reference preparation, and to preliminarily evaluate the bioequivalence of the test preparation (T) and the reference preparation (R), so as to provide a reference basis for the rationality of the blood collection time point and sample size design of the formal test. Secondary objective: To evaluate the safety of the test preparation and the reference preparation of sildenafil citrate tablets (specification: 50 mg) after a single oral administration on an empty stomach and after a meal in healthy male subjects in China.

A single-center, randomized, open, two-period crossover, single-dose design was used to compare the differences in the extent and rate of absorption of tadalafil tablets (test preparation, strength: 10 mg) provided by Chengdu Hengrui Pharmaceutical Co., Ltd. and tadalafil tablets (reference preparation, trade name: Cialis®, strength: 10 mg) licensed by A. Menarini GmbH in healthy men under fasting and postprandial administration conditions, and to evaluate the safety of the two preparations.