[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-cycle, crossover (fasting)/two-sequence, four-cycle, fully replicated crossover (postprandial) human bioequivalence trial of repaglinide tablets in healthy participants in China.
主要目的:观察中国健康试验参与者在空腹/餐后状态下单次口服受试制剂瑞格列奈片(规格:1.0mg;生产企业:浙江华润三九众益制药有限公司)和参比制剂瑞格列奈片(商品名:诺和龙®;规格:1.0mg;生产企业:德国Boehringer Ingelheim Pharma GmbH&Co.KG;持证商:Novo Nordisk A/S)后的药代动力学特征,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(诺和龙®)在中国健康试验参与者中的安全性。
[Translation] Primary Objective: To observe the pharmacokinetic characteristics of the test formulation repaglinide tablets (1.0 mg; manufactured by Zhejiang CR Sanjiu Zhongyi Pharmaceutical Co., Ltd.) and the reference formulation repaglinide tablets (trade name: Novo Nordisk®; 1.0 mg; manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany; licensee: Novo Nordisk A/S) after a single oral administration in healthy participants in a Chinese healthy trial, under fasting/postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting/postprandial conditions.
Secondary Objective: To observe the safety of the test formulation repaglinide tablets and the reference formulation repaglinide tablets (Novo Nordisk®) in healthy participants in a Chinese healthy trial.