[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to initially evaluate the efficacy and safety of peramivir inhalation solution in the treatment of uncomplicated uncomplicated influenza in adults.
主要研究目的:考察不同剂量、不同次数帕拉米韦吸入溶液对比安慰剂治疗成人无并发症的单纯性流感患者的安全性及有效性,为疗效确证阶段给药方案的确定提供依据。
次要研究目的:基于群体药代动力学(PopPK)分析方法,评价帕拉米韦吸入溶液在成人无并发症的单纯性流感患者中的 PK 特征及暴露-效应关系。
[Translation] Main research purpose: To investigate the safety and effectiveness of peramivir inhalation solution at different doses and different times compared with placebo in the treatment of adult patients with uncomplicated simple influenza, and to provide a basis for determining the dosage regimen during the efficacy confirmation phase.
Secondary research purpose: To evaluate the PK characteristics and exposure-effect relationship of peramivir inhalation solution in adult patients with uncomplicated simple influenza based on population pharmacokinetics (PopPK) analysis method.