[Translation] Bioequivalence study in healthy subjects administered in a single-center, randomized, open-label, single-dose, two-agent, two-cycle, two-sequence, double-crossover postprandial state.
本试验旨在研究餐后状态下口服单剂量磷酸西格列汀片(100 mg)四川制药制剂有限公司研制、生产的受试制剂与磷酸西格列汀片(100 mg)Merck Sharp & Dohme Ltd.生产的参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性,并观察两制剂的安全性。
[Translation] The purpose of this study is to investigate the oral administration of a single dose of sitagliptin phosphate tablets (100 mg) and the test preparation developed and produced by Sichuan Pharmaceutical Preparation Co. . For the produced reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞ of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the two preparations.