[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of fenelazol tablets administered orally to healthy participants after fasting.
主要研究目的:
研究空腹状态下单次口服受试制剂非奈利酮片(规格:20mg,浙江杭康药业有限公司生产)与参比制剂非奈利酮片(Kerendia®,规格:20mg,Bayer AG生产, Bayer AG持证)在健康成年试验参与者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
次要研究目的:
空腹状态下,研究单次口服受试制剂非奈利酮片和参比制剂非奈利酮片(Kerendia®)在健康成年试验参与者中的安全性。
[Translation] Primary Objective: To investigate the pharmacokinetics of a single oral dose of the test formulation fenelazol tablets (20 mg, manufactured by Zhejiang Hangkang Pharmaceutical Co., Ltd.) and the reference formulation fenelazol tablets (Kerendia®, 20 mg, manufactured by Bayer AG, licensed by Bayer AG) in healthy adult participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions.
Secondary Objective: To investigate the safety of a single oral dose of the test formulation fenelazol tablets and the reference formulation fenelazol tablets (Kerendia®) in healthy adult participants under fasting conditions.