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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy male subjects | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Azvudine suspension | Drug | A single oral dose of 3 mg/100 μCi of [14C]Azvudine suspension is given orally on an empty stomach. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of total radioactive material in whole blood and plasma | Up to 96 hours post-dose | |
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of total radioactive material in whole blood and plasma | Up to 96 hours post-dose | |
| Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of total radioactive material in whole blood and plasma | Up to 96 hours post-dose | |
| Pharmacokinetics (PK): Elimination half-life (t1/2) of total radioactive material in whole blood and plasma | Up to 96 hours post-dose | |
| The total radioactivity allocation ratio | Up to 96 hours post-dose | |
| The total radioactivity and the percentage to the total administered dose | Up to 168 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Azvudine and its metabolites in plasma | Up to 96 hours post-dose | |
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Azvudine and its metabolites in plasma | Up to 96 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hospital | Beijing | China |
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| Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of Azvudine and its metabolites in plasma | Up to 96 hours post-dose |
| Pharmacokinetics (PK): Elimination half-life (t1/2) of Azvudine and its metabolites in plasma | Up to 96 hours post-dose |
| Percentage of Azvudine metabolites in plasma to total exposed AUC | 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. | From enrollment to the end of the study on Day 22. |