Zhongshan Cococon Pharmaceutical Co., Ltd.

Main study objectives: To evaluate the bioequivalence of dapoxetine hydrochloride tablets developed and produced by Zhongshan Kekekang Pharmaceutical Co., Ltd. and dapoxetine hydrochloride tablets licensed by Berlin-Chemie AG in healthy Chinese male adult subjects after single oral administration on an empty stomach or after meals. Secondary objectives: To evaluate the safety of the test formulation and the reference formulation in healthy Chinese male adult subjects.

The main purpose of the study is to use the ibuprofen suspension (trade name: Meilin®; 100 mL: 2 g) certified by Shanghai Johnson Pharmaceutical Co., Ltd. as the reference preparation and the ibuprofen suspension (100 mL: 2 g) produced by Zhongshan Kekekang Pharmaceutical Co., Ltd. as the test preparation. The two preparations are evaluated for their bioequivalence in the fasting and fed state through a single-center, randomized, open, single-dose, two-preparation, two-period, double-crossover study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Main research purpose: This study uses Celecoxib Capsules (specification: 0.2 g) of Zhongshan Kekekang Pharmaceutical Co., Ltd. as the test preparation and Celecoxib Capsule (trade name: Celebrex®/Celebrex®, specification: 0.2 g) licensed by G.D.Searle LLC as the reference preparation to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects in the fasting and postprandial states, and evaluate the bioequivalence of the two preparations. Secondary research purpose: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.