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

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.

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.