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This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] Antaitavir Hasophate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] Antaitavir Hasophate | Experimental | Eligible healthy male subjects received a single oral 100 mg (radioactivity of 200µCi) dose of [14C] Antaitavir Hasophate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] Antaitavir Hasophate | Drug | 100 mg suspension containing 200µCi of [14C] Antaitavir Hasophate |
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| Measure | Description | Time Frame |
|---|---|---|
| Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate | To investigate the pharmacokinetics of total radioactivity in plasma after oral [14C] Antaitavir Hasophate in healthy subjects, and the distribution ratio of total radioactivity in whole blood and plasma | up to 15 days |
| Cumulative excretion of [14C] Antaitavir Hasophate -related material (radioactivity in plasma, urine and fecal samples) | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces. | up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of the Proportion of different metabolites to determine biotransformation pathway of Antaitavir Hasophate | Proportion of different metabolites(Antaitavir Hasophate and main metabolites) | up to 15 days |
| Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai xuhui central hospital | Shanghai | Shanghai Municipality | China |
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The concentrations of Antaitavir Hasophate and main metabolites in plasma |
| up to 15 days |
| Number of adverse events (AE) experienced by subjects | To examine the safety and tolerability of [14C] Antaitavir Hasophate given orally | up to 15 days |