[Translation] Single-center, randomized, open-label, single (fasting/postprandial) oral administration of agomelatine tablets in Chinese healthy subjects, two preparations, two sequences, four cycles, fully repetitive crossover human biology, etc. efficacy test
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] Main purpose: To observe the test preparation Agomelatine Tablets (specification: 25mg; holder: Shenzhen Pangu Pharmaceutical Co., Ltd.) and reference Pharmacokinetic characteristics of agomelatine tablets (trade name: Weixin®; strength: 25mg; licensee: Les Laboratoires Servier), and evaluation of the bioequivalence of the two preparations in fasting/postprandial states . Secondary objective: To observe the safety of test preparation agomelatine tablets and reference preparation agomelatine tablets (trade name: Weixin®) in healthy Chinese subjects.