[Translation] Single-center, randomized, open-label, two-formulation, single-dose, four-cycle, fully repeated crossover fasting/postprandial bioequivalence study of agomelatine tablets (25 mg) in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂阿戈美拉汀片(生产厂家:苏州第三制药厂有限责任公司)与参比制剂阿戈美拉汀片(持证商:Les Laboratoires Servier,商品名:Valdoxan®(维度新®))后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。次要目的:观察受试制剂阿戈美拉汀片和参比制剂阿戈美拉汀片在健康受试者中的安全性。
[Translation] Main purpose: Use pharmacokinetic parameters as the primary endpoint evaluation index to compare the oral administration of the test preparation agomelatine tablets (manufacturer: Suzhou Third Pharmaceutical Factory Co., Ltd.) and the reference in the fasting/postprandial state. Pharmacokinetic behavior in healthy subjects after preparing agomelatine tablets (licensee: Les Laboratoires Servier, trade name: Valdoxan®) to evaluate the bioequivalence of the two preparations . Secondary purpose: To observe the safety of test preparation agomelatine tablets and reference preparation agomelatine tablets in healthy subjects.