[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover controlled design was used to evaluate the bioequivalence of a single oral dose of sitagliptin and metformin tablets (Ⅱ) in the fasting and fed state.
研究空腹及餐后状态下单次口服受试制剂西格列汀二甲双胍片(Ⅱ)(规格:50mg/850mg(以西格列汀/盐酸二甲双胍计),多多药业有限公司生产)与参比制剂西格列汀二甲双胍片(Ⅱ)(商品名:JANUMET®/捷诺达®,规格:50mg/850mg(以西格列汀/盐酸二甲双胍计),持证商:MSD Merck Sharp & Dohme AG)在健康成年受试者体内的药代动力学,评价空腹及餐后状态下口服两种制剂的生物等效性。
次要目的:研究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)在健康成年受试者中的安全性。
[Translation] To study the pharmacokinetics of the test preparation Sitagliptin Metformin Tablets (II) (Specification: 50mg/850mg (based on sitagliptin/metformin hydrochloride), produced by Duoduo Pharmaceutical Co., Ltd.) and the reference preparation Sitagliptin Metformin Tablets (II) (Trade name: JANUMET®/Janoda®, Specification: 50mg/850mg (based on sitagliptin/metformin hydrochloride), licensee: MSD Merck Sharp & Dohme AG) in healthy adult subjects after a single oral administration in fasting and postprandial states, and to evaluate the bioequivalence of the two preparations when taken orally in fasting and postprandial states.
Secondary objective: To study the safety of the test preparation Sitagliptin Metformin Tablets (II) and the reference preparation Sitagliptin Metformin Tablets (II) in healthy adult subjects.