Azvudine(FNC),a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase (RdRp). This trial uses a single-center, open-label, single-dose adaptive design aimed at investigating the pharmacokinetic characteristics of total radioactivity of \[14C\]-labeled Azvudine in whole blood and plasma of healthy male subjects, to quantitatively analyze the total radioactivity in exhaled gas and excreta of healthy male subjects after oral administration of \[14C\]Azvudine suspension, to obtain data on the mass balance in the human body, and to determine the main excretion routes. Biological sample collection and safety examination will be performed in this trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
A single oral dose of 3 mg/100 μCi of \[14C\]Azvudine suspension is given orally on an empty stomach.
Beijing Jishuitan Hospital
Beijing, China
Pharmacokinetics (PK): Maximum Concentration (Cmax) of total radioactive material in whole blood and plasma
Time frame: Up to 96 hours post-dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of total radioactive material in whole blood and plasma
Time frame: Up to 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of total radioactive material in whole blood and plasma
Time frame: Up to 96 hours post-dose
Pharmacokinetics (PK): Elimination half-life (t1/2) of total radioactive material in whole blood and plasma
Time frame: Up to 96 hours post-dose
The total radioactivity allocation ratio
Time frame: Up to 96 hours post-dose
The total radioactivity and the percentage to the total administered dose
Time frame: Up to 168 hours post-dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Azvudine and its metabolites in plasma
Time frame: Up to 96 hours post-dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Azvudine and its metabolites in plasma
Time frame: Up to 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of Azvudine and its metabolites in plasma
Time frame: Up to 96 hours post-dose
Pharmacokinetics (PK): Elimination half-life (t1/2) of Azvudine and its metabolites in plasma
Time frame: Up to 96 hours post-dose
Percentage of Azvudine metabolites in plasma to total exposed AUC
Time frame: Up to 96 hours post-dose
Occurrence of Adverse Events
Clinical presentation characteristics, severity, onset time, duration of adverse events, management measures, outcomes, and the correlation with the investigational drug.
Time frame: From enrollment to the end of the study on Day 22.
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