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Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] HRS-5965 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] HRS-5965 | Drug | Patients will receive single dose of orally [14C] HRS-5965 on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total radioactive recovery rate in urine and feces at each time interval | 0-240 hours | |
| Cumulative total radioactive recovery rate in urine and feces | 0-240 hours | |
| 3. Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC) | 0-192 hours | |
| Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose) | 0-240 hours | |
| Radioactivity Tmax | 0-192 hours | |
| Radioactivity Cmax | 0-192 hours | |
| Radioactivity AUC | 0-192 hours | |
| Radioactivity t1/2 | 0-192 hours | |
| Radioactivity CL/F | 0-192 hours | |
| Radioactivity Vz/F | 0-192 hours | |
| Total radioactivity ratio for blood/plasma | 0-96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma HRS-5965: Tmax | 0-192 hours | |
| Plasma HRS-5965: Cmax | 0-192 hours | |
| Plasma HRS-5965: 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 Shandong First Medical University(Shandong Provincial Qianfoshan Hospital) | Jinan | Shandong | 250014 | China |
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Single oral dose of [14C] HRS-5965
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| 0-192 hours |
| Plasma HRS-5965: t1/2 | 0-192 hours |
| Plasma HRS-5965: CL/F | 0-192 hours |
| Plasma HRS-5965: Vz/F | 0-192 hours |
| Plasma HRS-5965: λz | 0-192 hours |
| AEs and SAEs | 0-11 days |