[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover bioequivalence study of sitagliptin and metformin tablets (II) in Chinese healthy subjects under fasting/fed conditions
主要研究目的
健康受试者空腹或餐后状态下,单次口服江西施美药业股份有限公司生产的受试制剂西格列汀二甲双胍片(Ⅱ)(规格:50mg/850mg)或Patheon Puerto Rico, Inc. (Manati)(United States)生产的参比制剂西格列汀二甲双胍片(Ⅱ)(商品名:捷诺达;规格:50mg/850mg),分别考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。
次要研究目的
考察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main study objectives
Healthy subjects were given a single oral dose of the test preparation Sitagliptin Metformin Tablets (II) (specification: 50mg/850mg) produced by Jiangxi Shimei Pharmaceutical Co., Ltd. or the reference preparation Sitagliptin Metformin Tablets (II) (trade name: JENODA; specification: 50mg/850mg) produced by Patheon Puerto Rico, Inc. (Manati)(United States) in the fasting or postprandial state to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects, respectively, and to evaluate the bioequivalence of the two preparations.
Secondary study objectives
Investigate the safety of the test preparation and the reference preparation in healthy subjects.