China Resources Saike Pharmaceutical Co., Ltd.

Main purpose: This study used safinamide mesylate tablets (specification: 100 mg) developed by China Resources Saike Pharmaceuticals Co., Ltd. as the test preparation. According to the relevant provisions of bioequivalence studies, safinamide mesylate tablets (specification: 100 mg, trade name: Xadago®) certified by Zambon S.p.A and produced by Catalent Germany Schorndorf GmbH were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose: Observe the safety of the test preparation safinamide mesylate tablets and the reference preparation safinamide mesylate tablets (trade name: Xadago®) in healthy subjects.

This study aimed to investigate the pharmacokinetic characteristics of ezetimibe tablets (10 mg) developed and produced by China Resources Saike Pharmaceuticals Co., Ltd. after single fasting and postprandial oral administration in healthy subjects; using ezetimibe tablets (Ezetimibe®, 10 mg) produced by MSD International GmbH (Singapore Branch) as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the human bioequivalence of the two preparations was evaluated, and the safety of the two preparations in healthy subjects was observed.

Main purpose: This study used Linagliptin Metformin Tablets (II) (Specification: 2.5 mg/850 mg) developed by China Resources Saike Pharmaceuticals Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, Linagliptin Metformin Tablets (II) (Specification: 2.5 mg/850 mg, trade name: Oushuangning®) produced by the original manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG was used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose: Observe the safety of the test preparation Linagliptin Metformin Tablets (II) and the reference preparation Linagliptin Metformin Tablets (II) (Oushuangning®) in healthy subjects.