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| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
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This study is a single center, single dose, non-randomized, open design clinical study.By quantitative analysis of the biological samples of subjects after oral administration of [14C]JT001, the data of human radioactive excretion rate and the main excretion pathway will be obtained. The main metabolites ,metabolic pathways and elimination pathways of JT001 will be identified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]JT001 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]JT001 | Drug | Subjects will receive approximately 300 mg/100 µCi of [14C]JT001 orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total radioactive recovery | The percentage of radioactivity recovered from collected samples | 1 month |
| cumulative excretion rate of total radioactive material in fecal matter | After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces | 1 month |
| Peak concentration(Cmax) | The highest plasma drug concentration that can be achieved after medication | 1 month |
| time to peak(Tmax) | After a single dose, the time of peak blood concentration | 1 month |
| elimination half life(t1/2) | the time it takes the blood to reduce the concentration of the drug to half | 1 month |
| Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS) | The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Number of cases and incidence of adverse events(AEs) | 2 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
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Single Group
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