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The purpose of the study is to analyze absorption, metabolism, excretion, mass balance and biotransformation after a single oral dose of [14C]TNP-2198 in healthy male participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]TNP-2198 | Experimental | Participants will take a single dose of 600mg 150μCi of [14C]TNP-2198. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]TNP-2198 | Drug | 600mg suspension containing 150μCi of [14C] TNP-2198 |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion rate of total radioactivity in excreta (urine and feces) | Quantitative analysis of total radioactivity in excreta after oral [14C] TNP-2198 in healthy volunteers | 0 hour(24 hours before administration) to 312 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results |
| Pharmacokinetics (PK) (AUC0-inf) for TNP-2198 and total radioactivity in plasma and whole blood | Assessment of pharmacokinetics of TNP-2198 and total radioactivity by measuring the concentration time curve from time zero extrapolated to infinity (AUC0-inf) | 0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results |
| PK (AUC0-t) for TNP-2198 and total radioactivity in plasma and whole blood | Assessment of pharmacokinetics of TNP-2198 and total radioactivity by measuring the concentration time curve from time zero to the last measureable concentration (AUC0-t) | 0 hour (-60 minutes) before administration to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results |
| PK (Cmax ) for TNP-2198 and total radioactivity in plasma and whole blood | Cmax (maximum observed concentration) | 0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results |
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Inclusion Criteria:
Exclusion Criteria:
Those who meet any of the following criteria will not be included:
Auxiliary examinations:
Medication history:
Medical and surgical history:
Living habits:
Others:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
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