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This study is a single-center, open-label, single-dose design. It is planning to enroll six Chinese healthy adult male subjects. The metabolism and disposition of Herombopag, will be studied in these subjects after a single oral administration of a solution dose of [14C] Herombopag (5 mg, 100 uCi).
The metabolism and disposition of Herombopag, will be studied in six healthy men after a single oral administration of a solution dose of [14C]eltrombopag (5 mg,100 uCi).
The sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma 、quantitatively analyze the the total radioactivity in the excreta、evaluate the predominant route of elimination and indentify the Metabolite profiles in plasma 、urine and faces.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hetrombopag Olamine | Experimental | Hetrombopag Olamine (5 mg, 100 uCi) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag Olamine | Drug | a single oral taking |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity pharmacokinetics in whole blood and plasma | plasma concentration of total radioactivity | From 1 hour before administration to 240 hours after administration |
| total radioactivity in the excreta | Excretion of radioactivity in human urine and feces | From 24 hour before administration to 336 hours after administration |
| the concentration of Hetrombopag in plasma | Area under the plasma concentration versus time curve (AUC) | From 1 hour before administration to 240 hours after administration |
| individual metabolite profiles in plasma 、urine and faces | Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse individual percentage of metabolites. | From 24 hour before administration to 336 hours after administration |
| mean metabolite profiles in plasma 、urine and faces | Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse mean percentage of metabolites. | From 24 hour before administration to 336 hours after administration |
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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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