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This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31679 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 160 mg/100 μCi [14C]HSK31679 | Experimental | [14C]HSK31679 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]HSK31679 | Drug | A single oral dose of 160 mg/100 μCi [14C]HSK31679 after fasting for at least 10 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance | Percentage of cumulative drug excretion of [14C]HSK31679 on biological pecimens(urine and faeces) accounting for total radiation drug dose | From the start of administration to 240 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t) | The pharmacokinetic parameters of HSK31679 and major metabolites (if applicable) in plasma | From the start of administration to 240 hours after administration |
| AUC(0-∞) | The pharmacokinetic parameters of HSK31679 and major metabolites (if applicable) in plasma |
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Inclusion Criteria:
Exclusion Criteria:
Male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) | Jinan | Shandong | China |
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| From the start of administration to 240 hours after administration |
| Cmax | The pharmacokinetic parameters of HSK31679 and major metabolites (if applicable) in plasma | From the start of administration to 240 hours after administration |