[Translation] Bioequivalence study of fenelazol tablets in healthy participants under single-center, randomized, open-label, two-period, two-sequence, two-crossover, single-dose fasting administration.
主要目的:
本研究以多多药业有限公司持有的非奈利酮片(规格:10 mg)为受试制剂,按生物等效性研究的有关规定,以Bayer AG持证的非奈利酮片[规格:10 mg ,商品名:Kerendia(可申达)®]为参比制剂,评估受试制剂和参比制剂在空腹条件下给药后的生物等效性。
次要目的:
观察受试制剂非奈利酮片和参比制剂非奈利酮片[Kerendia(可申达)®]在健康试验参与者中的安全性。
[Translation] Primary Objective: This study used fenelazol tablets (10 mg) manufactured by Duoduo Pharmaceutical Co., Ltd. as the test formulation and, in accordance with the relevant regulations for bioequivalence studies, used fenelazol tablets [10 mg, trade name: Kerendia®] manufactured by Bayer AG as the reference formulation to evaluate the bioequivalence of the test and reference formulations after administration under fasting conditions.
Secondary Objective: To observe the safety of the test and reference formulations, fenelazol tablets [Kerendia®], in healthy trial participants.