[Translation] A 12-week double-blind, placebo-controlled, randomized, parallel, multicenter study on the efficacy and safety of Soanfitol in the treatment of excessive daytime sleepiness (EDS) in patients with obstructive sleep apnea syndrome (OSA)
主要目的:
评估索安非托治疗成人OSA患者的EDS的疗效。
次要目的:
评估索安非托治疗成人OSA患者的EDS的安全性和耐受性。
通过稀疏采样法评估索安非托在成人OSA伴EDS患者体内的药代动力学( PK)特征。
[Translation] Primary objective:
To evaluate the efficacy of Soanfitol in the treatment of EDS in adult patients with OSA.
Secondary objective:
To evaluate the safety and tolerability of Soanfitol in the treatment of EDS in adult patients with OSA.
The pharmacokinetic (PK) characteristics of Soanfitol in adult patients with OSA and EDS were evaluated by sparse sampling method.