[Translation] Randomized, open, single-dose, two-dose, two-sequence, two-period, self-crossover control design, evaluating Chinese healthy subjects in a single oral administration of sitagliptin and metformin tablets (I)/(II) under fasting and postprandial states After the formal test of bioequivalence
主要目的:以浙江永太药业有限公司提供的西格列汀二甲双胍片(I)或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Patheon Puerto Rico, Inc.(Manati)生产的西格列汀二甲双胍片(I)或西格列汀二甲双胍片(II)(商品名:JANUMET®/捷诺达®,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(I)/(II)和参比制剂西格列汀二甲双胍片(I)/(II)(JANUMET®/捷诺达®)在健康受试者中的安全性。
[Translation] Main purpose: take sitagliptin metformin tablets (I) or sitagliptin metformin tablets (II) provided by Zhejiang Yongtai Pharmaceutical Co., Ltd. Sitagliptin Metformin Tablets (I) or Sitagliptin Metformin Tablets (II) produced by Rico, Inc. (Manati) (trade name: JANUMET®/Jianoda®, reference preparation) were compared in healthy subjects The absorption rate and degree of absorption were used to investigate the human bioequivalence of the two preparations.
Secondary purpose: To observe the effect of the test preparation sitagliptin metformin tablets (I)/(II) and the reference preparation sitagliptin metformin tablets (I)/(II) (JANUMET®/Jianoda®) in healthy subjects. safety among test takers.