[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of repaglinide tablets in healthy Chinese subjects using two formulations, two sequences, two cycles, and a crossover approach
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] Primary objective: To observe the pharmacokinetic characteristics of the test preparation repaglinide tablets (specification: 2.0 mg; manufacturer: Nanjing Haina Pharmaceutical Co., Ltd.) and the reference preparation repaglinide tablets (trade name: NovoNorm; specification: 2.0 mg; licensee: Novo Nordisk A/S) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, to compare the key pharmacokinetic parameters, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary objective: To observe the safety of the test preparation repaglinide tablets and the reference preparation repaglinide tablets (NovoNorm) in healthy Chinese subjects.