[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of sitagliptin and metformin tablets in healthy subjects on an empty stomach or after a meal
主要研究目的: 研究空腹和餐后状态下单次口服受试制剂西格列汀二甲双胍片(规格:西格列汀50mg/二甲双胍850mg,浙江英格莱制药有限公司生产)与参比制剂西格列汀二甲双胍片(II)(捷诺达®,规格:西格列汀50mg/二甲双胍850mg,MSD Pharma(Singapore)Pte.Ltd持证,Patheon Puerto Rico,Inc.(Manati)生产)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的: 空腹和餐后状态下,研究单次口服受试制剂西格列汀二甲双胍片和参比制剂西格列汀二甲双胍片(II)(捷诺达®)在健康成年受试者中的安全性。
[Translation] Primary study objective: To study the pharmacokinetics of the test preparation Sitagliptin Metformin Tablets (Specifications: Sitagliptin 50mg/Metformin 850mg, produced by Zhejiang Ingel Pharmaceutical Co., Ltd.) and the reference preparation Sitagliptin Metformin Tablets (II) (Janoda®, Specifications: Sitagliptin 50mg/Metformin 850mg, licensed by MSD Pharma (Singapore) Pte. Ltd, produced by Patheon Puerto Rico, Inc. (Manati)) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state.
Secondary study objective: To study the safety of the test preparation Sitagliptin Metformin Tablets and the reference preparation Sitagliptin Metformin Tablets (II) (Janoda®) in healthy adult subjects after a single oral administration in the fasting and fed state.