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Evaluate the Mass Balance of [14C]SHR7280 in Healthy Adult Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]SHR7280 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]SHR7280 | Drug | Patients will receive single dose of orally [14C]SHR7280 on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative recovery and recovery rate of total radioactive substance in urine and feces | 0-240 hours | |
| Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC) | 0-120 hours | |
| Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose) | 0-240 hours | |
| Radioactivity Tmax | 0-120 hours | |
| Radioactivity Cmax | 0-120 hours | |
| Radioactivity AUC | 0-120 hours | |
| Radioactivity t1/2 | 0-120 hours | |
| Radioactivity CL/F | 0-120 hours | |
| Radioactivity Vz/F | 0-120 hours | |
| Total radioactivity ratio for blood/plasma | 0-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma SHR7280: Tmax | 0-120 hours | |
| Plasma SHR7280: Cmax | 0-120 hours | |
| Plasma SHR7280: AUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu | 215008 | China |
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Single oral dose of [14C]SHR7280
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| 0-120 hours |
| Plasma SHR7280: t1/2 | 0-120 hours |
| Plasma SHR7280: CL/F | 0-120 hours |
| Plasma SHR7280: Vz/F | 0-120 hours |
| Plasma SHR7280: λz | 0-120 hours |
| AEs and SAEs | Screening to 10 days |