At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
nintedanib 25 mg +1 moredrug
Likely dose
nintedanib 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating nintedanib 25 mg and nintedanib 100 mg for Healthy. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedJun 2021
Enrollment StartJul 2021
Primary CompletionAug 2021
TodayJul 2026
First PostedJun 24, 2021
Enrollment StartJul 14, 2021
Primary CompletionAug 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.0 years ago
Interventions
nintedanib 25 mgdrug
soft gelatin capsule
nintedanib 100 mgdrug
soft gelatin capsule