Trials / Completed
CompletedNCT05262751
A Study in Healthy Men to Find the Best Formulation for Once Daily Intake of Nintedanib
A Phase I Study for Formulation Selection and Subsequent Optimization of Two Different Oral Formulations of Nintedanib in Healthy Male Subjects (Open-label, Randomised, Single-dose Study in Three Parts)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this trial is to assess single dose drug exposure of several newly developed formulation prototypes of Nintedanib compared to Ofev® following oral administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ofev® | Ofev® |
| DRUG | Nintedanib formulation 1 | Nintedanib formulation 1: Monolithic Nintedanib Modified Release Tablet (MR1) as two Prototypes (MR1-1 and MR1-2). |
| DRUG | Nintedanib formulation 2 | Nintedanib formulation 2: Polyox Nintedanib Modified Release Tablet (MR2) as two Prototypes (MR2-1 and MR2-2). |
Timeline
- Start date
- 2022-03-28
- Primary completion
- 2022-11-30
- Completion
- 2022-11-30
- First posted
- 2022-03-02
- Last updated
- 2024-05-29
- Results posted
- 2024-05-29
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05262751. Inclusion in this directory is not an endorsement.