Trial | NCT04816123  Report issue

Title

The Mass Balance and Biotransformation of [14C]Donafenib in Healthy Adult Man
The Mass Balance and Biotransformation Study of [14C] Donafenib in Chinese Healthy Adult Male Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    6
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 Started
Oct 09
2018
Primary Completion
Dec 18
2018
Study Completion
Dec 18
2018
Last Update
Mar 25
2021

Drug [14C]Donafenib

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.

[14C]Donafenib Experimental

Criteria 

Inclusion Criteria:

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 Criteria:

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.
No Results Posted