Status:
COMPLETED
The Mass Balance and Biotransformation of [14C]Donafenib in Healthy Adult Man
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Healthy Male Adult
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- A healthy male adult.
- Age is between 18 and 45, inclusive.
- Body mass index is between 19 and 26, inclusive.
- Voluntarily to provide informed consent form.
- Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.
Exclusion
- Any abnormal and clinical significant findings.
- A positive examination result of HBsAg/HBeAg, HIV antibody and treponema pallidum antibody.
- Volunteers who had participated in a radiolabeled clinical study or were exposed to significant levels of radiation for any reasons within the 12 months prior to the study.
- Volunteers who had used of prescription or herbal products that may affect the drug metabolism within 30 days before the study.
- Volunteers who had blood loss/donation up to 400 mL within 3 months before the screening, or received blood transfusion within 1 month.
Key Trial Info
Start Date :
October 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04816123
Start Date
October 9 2018
End Date
December 18 2018
Last Update
March 25 2021
Active Locations (1)
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1
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China, 215006