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To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HSK39297
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]HSK39297 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon-14 labeled HSK39297 | Drug | Dose A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of total radioactivity in urine and fecal samples | Mass balance recovery of total radioactivity in urine and fecal samples | Up to 312 hours post dose |
| Total radioactivity in plasma PK | PK parameters of total radioactivity in the plasma; Ratio of total radioactivity concentration in whole blood/plasma at different time points. | Up to 312 hours post dose. |
| Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples | Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites | Up to 312 hours post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms and ophthalmological assessments | Up to 312 hours post dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
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| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |