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This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]Vicagrel orally in Chinese healthy male volunteers, revealing the overall pharmacokinetic characteristics of vicagrel in humans, and providing a reference for the rational administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]Vicagrel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Vicagrel | Drug | Take a suspension of 20 mg vicagrel ,containing about 120 μCi [14C]Vicagrel, in fasting within 5 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Total radioactive datas in blood | Total radioactive distribution and pharmacokinetics in blood and plasma | from 0 hour to 240 hours after administration |
| Total radioactive datas in excreta | Total radioactive distribution and pharmacokinetics in urine and feces; the main routes of [14C]Vicagrel excretion in human | from 0 hour to 240 hours after administration |
| Peak Plasma Concentration (Cmax) | Determine the Cmax of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma | from 0 hour to 240 hours after administration |
| Area under the plasma concentration versus time curve (AUC) | Determine the AUC of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma | from 0 hour to 240 hours after administration |
| Time of Peak Plasma Concentration(Tmax) | Determine the Tmax of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma | from 0 hour to 240 hours after administration |
| Drug half-life in plasma(t1/2) | Determine the T1/2 of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma | from 0 hour to 240 hours after administration |
| Mean Residence Time (MRT) | Determine the MRT of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma | from 0 hour to 240 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Review the relationship between investigational products and all the abnormal and clinically significant findings | through the completion of study, an average of 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, PhD | First Affiliated Hospital of Suzhou Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu | China |
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single arm with single dose of 20mg vicagrel, containing about 120μCi [14C]Vicagrel
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unrandomization and open labeled study
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| Numbers of Vicagrel Metabolites | Detect Vicagrel Metabolites in blood, feces and urines as much as possible to clear the main routes of biotransformation | from 0 hour to 240 hours after administration |