[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of agomelatine tablets in healthy Chinese subjects: two-formulation, two-sequence, four-period, complete repeated crossover
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂阿戈美拉汀片(规格:25mg;持有人:深圳市泛谷药业股份有限公司)和参比制剂阿戈美拉汀片(商品名:维度新®;规格:25mg;持证商:Les Laboratoires Servier)后的药代动力学特征,评价空腹/餐后状态下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(商品名:维度新®)在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation agomelatine tablets (specification: 25 mg; holder: Shenzhen Fangu Pharmaceutical Co., Ltd.) and the reference preparation agomelatine tablets (trade name: Weiduxin®; specification: 25 mg; licensee: Les Laboratoires Servier) in Chinese healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation agomelatine tablets and the reference preparation agomelatine tablets (trade name: Weiduxin®) in Chinese healthy subjects.