Chongqing Pharscin Pharmaceutical Co., Ltd.

1. Primary objective: To investigate the pharmacokinetic parameters and relative bioavailability of apalutamide tablets produced by Chongqing Huasen Pharmaceutical Co., Ltd. and apalutamide tablets (Erleada®) produced by Janssen-Cilag International NV in healthy Chinese subjects, and to evaluate the bioequivalence of the test and reference preparations when administered under fasting and postprandial conditions. 2. Secondary objective: To observe the safety of the test and reference preparations in healthy subjects.

This study aimed to investigate the pharmacokinetic characteristics of piribedil sustained-release tablets (50 mg) developed and produced by Chongqing Huasen Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Piribedil sustained-release tablets (Trastal®/Tastal®, 50 mg) produced by Les Laboratoires Servier Industrie were used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

To investigate the pharmacodynamic differences between orlistat capsules (test preparation T, strength: 60 mg) provided by Chongqing Huasen Pharmaceutical Co., Ltd. and orlistat capsules (reference preparation R, trade name: Alli®, strength: 60 mg) certified by Glaxo SmithKline Consumer Healthcare after repeated administration in healthy subjects, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.