[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, self-crossover controlled study was conducted to evaluate the bioequivalence of a single oral dose of sitagliptin and metformin tablets (I)/(II) in Chinese healthy subjects in the fasting and fed state.
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] Primary objective: Sitagliptin Metformin Tablets (I) or Sitagliptin Metformin Tablets (II) provided by Zhejiang Yongtai Pharmaceutical Co., Ltd. were used as the test preparations. According to the relevant provisions of the bioequivalence test, the absorption rate and degree of Sitagliptin Metformin Tablets (I) or Sitagliptin Metformin Tablets (II) (trade name: JANUMET®/Janoda®, reference preparation) produced by Patheon Puerto Rico, Inc. (Manati) were compared in healthy subjects to investigate the bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test preparation Sitagliptin Metformin Tablets (I)/(II) and the reference preparation Sitagliptin Metformin Tablets (I)/(II) (JANUMET®/Janoda®) in healthy subjects.