Ginkgo Pharmaceutical (Suzhou) Co., Ltd.

Main study objectives To evaluate the pharmacokinetic characteristics of GP681/GP1707D07 in subjects with mild hepatic impairment (Child-Pugh: Class A), moderate hepatic impairment (Child-Pugh: Class B) and normal hepatic function, and to provide a basis for the clinical application of GP681 tablets. Secondary study objectives To evaluate the safety of GP681 tablets in subjects with mild hepatic impairment (Child-Pugh: Class A), moderate hepatic impairment (Child-Pugh: Class B) and normal hepatic function.

Main study objectives 1) To evaluate the effect of GP681 tablets on the pharmacokinetic characteristics of rosuvastatin (cohort 1) and digoxin (cohort 2) in healthy Chinese subjects; 2) To evaluate the effect of multiple doses of itraconazole (cohort 3) on the pharmacokinetic characteristics of GP681 and its major metabolite GP1707D07 in healthy Chinese subjects; 3) To evaluate the pharmacokinetic interaction of GP681 and oseltamivir (cohort 4) in healthy Chinese subjects; Secondary study objectives To evaluate the safety of oral GP681 tablets in combination with rosuvastatin calcium tablets, digoxin tablets, itraconazole capsules, and oseltamivir phosphate capsules in healthy Chinese subjects. Exploratory objectives To explore the effects of CYP450 metabolizing enzyme and transporter gene polymorphisms on the pharmacokinetic characteristics and drug interactions of GP681 and its major metabolite GP1707D07 in healthy subjects.

Main study objectives: To evaluate the effectiveness of a single oral dose of GP681 tablets compared with placebo in the treatment of children, adolescents and adults with uncomplicated acute influenza by measuring the time of influenza symptom relief in children, adolescents and adults with uncomplicated acute influenza. Secondary study objectives: 1) To evaluate the effectiveness of GP681 tablets in the treatment of children, adolescents and adults with uncomplicated acute influenza through other secondary endpoints; 2) To evaluate the safety of GP681 tablets in the treatment of children, adolescents and adults with uncomplicated acute influenza; 3) To evaluate the pharmacokinetic (PK) characteristics of GP681 tablets in children, adolescents and adults with uncomplicated acute influenza, and to establish a corresponding exposure response model based on previous clinical research data.