Trials / Completed
CompletedNCT04816123
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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 characteristics of Donafenib in humans, and providing a reference for the rational administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-10-09
- Primary completion
- 2018-12-18
- Completion
- 2018-12-18
- First posted
- 2021-03-25
- Last updated
- 2021-03-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04816123. Inclusion in this directory is not an endorsement.