[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence bioequivalence study of sitagliptin and metformin tablets (II) in healthy subjects under fasting and fed conditions
主要目的:以吉林长白山药业集团股份有限公司提供的西格列汀二甲双胍片(II)为受试制剂,按生物等效性试验的有关规定,与MSD Pharma(Singapore)Pte.Ltd公司持证的西格列汀二甲双胍片(II)(商品名:JANUMET®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂西格列汀二甲双胍片(II)和参比制剂西格列汀二甲双胍片(II)(JANUMET®)在健康受试者中的安全性。
[Translation] Primary objective: Sitagliptin Metformin Tablets (II) provided by Jilin Changbaishan Pharmaceutical Group Co., Ltd. was used as the test preparation. According to the relevant provisions of the bioequivalence test, the absorption rate and degree of Sitagliptin Metformin Tablets (II) (trade name: JANUMET®, reference preparation) certified by MSD Pharma (Singapore) Pte. Ltd. were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test preparation Sitagliptin Metformin Tablets (II) and the reference preparation Sitagliptin Metformin Tablets (II) (JANUMET®) in healthy subjects.