At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Rosuvastatin +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.
Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1358894 in Healthy Male Subjects (Open, Single-dose, Fixed Sequence, Two-period Crossover Design in Each Trial Part)
In Brief
A Phase 1 clinical trial evaluating Rosuvastatin, BI 1358894, and 1 other intervention for Healthy. Completed, enrolled 26 participants across 1 site.
Detailed Summary
The main objective of this trial is to investigate the relative bioavailability of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1358894 (Test 1, Test 2) following oral administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartOct 2019
Primary CompletionDec 2019
TodayJul 2026
First PostedSep 23, 2019
Enrollment StartOct 7, 2019
Primary CompletionDec 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.8 years ago
Interventions
Rosuvastatindrug
Tablet
BI 1358894drug
Tablet
Dabigatran etexilatedevice
Capsule