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This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]Donafenib orally in Chinese healthy adult male volunteers, revealing the overall pharmacokinetic characteristics of Donafenib in humans, and providing a reference for the rational administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]Donafenib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Donafenib | Drug | Each volunteers received a single 300 mg dose of [14C]donafenib (toluene sulfonic acid) containing a radioactivity dose of 120 μCi as an oral suspension, in fasting within 5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitive analysis of whole radioactivity of excrement of orally administered [14]Donafenib in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body | The percentage of radioactive dose of [14C] radiolabelled Donafenib recovered in urine, faeces and in total | from 0 hour to 240 hours after administration |
| Identification of the main metabolite and biotransformation pathway of Donafenib and investigation of metabolite in plasma by LC-RAM/HRMS | Proportion of different metabolites | from 0 hour to 240 hours after administration |
| Quantitive analysis of the concentrations of Donafenib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data | The concentrations of Donafenib 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 | Up to 7 days (approx) from the start of administration |
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Inclusion Criteria:
Exclusion Criteria:
Male
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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 | 215006 | China |
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single arm with single dose of 300mg Donafenib, containing about 120μCi [14C]Donafenib
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Nonrandomized and open labeled study
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