At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Rosuvastatin +3 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 1323495 in Healthy Male Subjects (Open, Single-dose, Randomised, Two-period Crossover Design in Each Trial Part)
In Brief
A Phase 1 clinical trial evaluating Rosuvastatin, Rosuvastatin + BI 1323495, and 2 other interventions for Healthy. Completed, enrolled 28 participants across 1 site.
Detailed Summary
The main objectives of this trial are to investigate the relative bioavailabilities of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1323495 (Test 1, Test 2) following oral administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedFeb 2020
Enrollment StartFeb 2020
Primary CompletionSep 2020
TodayJul 2026
First PostedFeb 5, 2020
Enrollment StartFeb 13, 2020
Primary CompletionSep 23, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.4 years ago
Interventions
Rosuvastatindrug
Tablet
Rosuvastatin + BI 1323495drug
Tablets
Dabigatran etexilatedrug
Capsule
Dabigatran etexilate + BI 1323495drug
Capsule and tablets