[Translation] A multicenter, randomized, double-blind, double-dummy, positive-controlled study to evaluate the safety, pharmacokinetics, and efficacy of ADC189 tablets/granules in children aged 2 to 11 years with influenza
主要目的:评价ADC189片/颗粒治疗儿童流感受试者的安全性。
次要目的:(1)评价ADC189片/颗粒在儿童流感受试者中活性代谢产物ADC189-I07的药代动力学(PK)特征;并评估ADC189-I07暴露-效应关系。(2)评价ADC189片/颗粒治疗儿童流感受试者的有效性。(3)评价ADC189片/颗粒在儿童流感受试者中的耐药性。
[Translation] Primary objective: To evaluate the safety of ADC189 tablets/granules in treating pediatric influenza subjects.
Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of the active metabolite ADC189-I07 of ADC189 tablets/granules in pediatric influenza subjects; and to assess the exposure-effect relationship of ADC189-I07. (2) To evaluate the efficacy of ADC189 tablets/granules in treating pediatric influenza subjects. (3) To evaluate the drug resistance of ADC189 tablets/granules in pediatric influenza subjects.