[Translation] A randomized, open-label, single-dose, postprandial, two-sequence, four-cycle repeat crossover design bioequivalence trial of agomelatine tablets in healthy subjects
主要目的:
考察重庆华森制药股份有限公司生产的阿戈美拉汀片和Les Laboratoires Servier生产的的阿戈美拉汀片(Valdoxan®)的药代动力学参数和相对生物利用度,评估受试制剂和参比制剂在餐后条件下给药时的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] main purpose:
The pharmacokinetic parameters and relative bioavailability of agomelatine tablets produced by Chongqing Huasen Pharmaceutical Co., Ltd. and agomelatine tablets (Valdoxan®) produced by Les Laboratoires Servier were investigated. Bioequivalence of the reference formulation when administered under postprandial conditions.
Secondary objective: To observe the safety of the test product and the reference product in healthy subjects.