[Translation] A single-center, randomized, open-label, single (fasting/after meal) oral administration, two preparations, two sequences, two cycles, crossover human bioequivalence study of repaglinide tablets in Chinese healthy subjects
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂瑞格列奈片(规格:2.0mg;生产企业:南京海纳制药有限公司)和参比制剂瑞格列奈片(商品名:NovoNorm;规格:2.0mg;持证商:Novo Nordisk A/S)后的药代动力学特征,进行药代动力学关键参数的比较,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂瑞格列奈片和参比制剂瑞格列奈片(NovoNorm)在中国健康受试者中的安全性。
[Translation] Main purpose: To observe Chinese healthy subjects taking a single oral administration of repaglinide tablets (specification: 2.0mg; manufacturer: Nanjing Haina Pharmaceutical Co., Ltd.) and reference preparation repaglinide Pharmacokinetic characteristics of sodium tablets (trade name: NovoNorm; specification: 2.0mg; licensee: Novo Nordisk A/S), compared the key parameters of pharmacokinetics, and evaluated the fasting/postprandial status of the two Bioequivalence of formulations.
Secondary purpose: To observe the safety of the test preparation repaglinide tablets and the reference preparation repaglinide tablets (NovoNorm) in Chinese healthy subjects.