[Translation] A single-center, randomized, open-label, two-dose, single-dose, four-period, completely repeated crossover fasting/fed 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] Primary objective: To compare the pharmacokinetic parameters as the primary endpoints of the pharmacokinetic behavior of the test preparation agomelatine tablets (manufacturer: Suzhou Third Pharmaceutical Factory Co., Ltd.) and the reference preparation agomelatine tablets (licensed by: Les Laboratoires Servier, trade name: Valdoxan®) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation agomelatine tablets and the reference preparation agomelatine tablets in healthy subjects.