Trials / Completed
CompletedNCT04938453
A Study in Healthy Men to Test Whether Four Capsules of 25 mg Nintedanib Are Taken up in the Body in the Same Way as One 100 mg Capsule
Relative Bioavailability of 100 mg Nintedanib (Ofev®) Given as Four Capsules of 25 mg Compared to One Capsule of 100 mg Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this trial is to investigate the relative bioavailability of 100 mg nintedanib given as four capsules of 25 mg nintedanib compared with one capsule of 100 mg nintedanib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nintedanib 25 mg | soft gelatin capsule |
| DRUG | nintedanib 100 mg | soft gelatin capsule |
Timeline
- Start date
- 2021-07-14
- Primary completion
- 2021-08-30
- Completion
- 2021-08-30
- First posted
- 2021-06-24
- Last updated
- 2023-07-17
- Results posted
- 2023-07-17
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04938453. Inclusion in this directory is not an endorsement.