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Clinical Trials associated with CB345 / Not yet recruitingPhase 1 CB345 膜剂在健康参与者中的安全性和药代动力学特征及与对照制剂阿戈美拉汀片相对生物利用度的 I 期临床研究
[Translation] A Phase I clinical study of the safety and pharmacokinetic characteristics of CB345 film formulation in healthy participants and its relative bioavailability compared to the control formulation agomelatine tablets.
主要目的是评价健康参与者单次给药CB345膜剂的药代动力学特征。同时评价健康参与者单次给药CB345膜剂的安全性、考察单次给药膜剂及单次口服阿戈美拉汀片的药代动力学特征,评价两制剂间相对生物利用度(F),评价口腔不同给药部位对CB345膜剂药代动力学特征的影响和评价CB345膜剂的适口性。
[Translation] The primary objective was to evaluate the pharmacokinetic characteristics of a single-dose CB345 film formulation in healthy participants. Simultaneously, the safety of a single-dose CB345 film formulation in healthy participants was assessed, the pharmacokinetic characteristics of a single-dose film formulation and a single oral agomelatine tablet were examined, the relative bioavailability (F) between the two formulations was evaluated, the impact of different oral administration sites on the pharmacokinetic characteristics of the CB345 film formulation was evaluated, and the palatability of the CB345 film formulation was assessed.
100 Clinical Results associated with CB345
100 Translational Medicine associated with CB345
100 Patents (Medical) associated with CB345
100 Deals associated with CB345