[Translation] Bioequivalence study of fenelazol tablets in healthy trial participants in a randomized, open-label, two-formulation, single-dose, two-period, two-sequence fasting trial.
主要目的:以武汉人福利康药业有限公司提供的非奈利酮片为受试制剂,按生物等效性试验的有关规定,与Bayer AG公司持证的非奈利酮片(商品名:可申达®,参比制剂)对比在健康试验参与者体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察非奈利酮片受试制剂和参比制剂(可申达®)在健康试验参与者中的安全性。
[Translation] Primary objective: To investigate the bioequivalence of fenelazol tablets (provided by Wuhan Renfulikang Pharmaceutical Co., Ltd.) in healthy trial participants, comparing their absorption rate and extent with that of fenelazol tablets (trade name: Keshenda®, reference formulation) certified by Bayer AG, in accordance with relevant bioequivalence testing regulations.
Secondary objective: To observe the safety of the fenelazol tablet test formulation and the reference formulation (Keshenda®) in healthy trial participants.