At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 70 enrolled
Drug / intervention
Nintedanib +2 moredrug
Likely dose
Not stated in 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.
Bioequivalence of 1 Soft Gelatine Capsule Containing 200 mg Nintedanib Compared to 2 Soft Gelatine Capsules Containing 100 mg Nintedanib Following Oral Administration in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating Nintedanib for Healthy. Completed, enrolled 70 participants across 1 site.
Detailed Summary
To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedOct 2015
Primary CompletionNov 2015
TodayJul 2026
First PostedOct 9, 2015
Enrollment StartAug 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.7 years ago
Interventions
Nintedanibdrug
1 soft gelatine capsule, single dose, oral
Nintedanibdrug
Nintedanib, 2 soft gelatine capsules, single dose, oral
Nintedanibdrug