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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
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.
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
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
Time frame: 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
Time frame: 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
Time frame: from 0 hour to 240 hours after administration
Adverse Events
Review the relationship between investigational products and all the abnormal and clinically significant findings
Time frame: Up to 7 days (approx) from the start of administration
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