At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 54 enrolled
Drug / intervention
Dabigatran etexilate +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 Dabigatran After Administration of Different Dosage Forms of Multiple Doses of 150 mg Dabigatran Etexilate (Hard Capsule, Granules Resolved in Reconstitution Solution, Pellets on Food) in Healthy Male Volunteers (an Open-label, Randomised, Multiple-dose, Three Way Crossover Study)
In Brief
A Phase 1 clinical trial evaluating Dabigatran etexilate for Healthy. Completed, enrolled 54 participants across 1 site.
Detailed Summary
To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedJan 2014
Primary CompletionApr 2014
TodayJul 2026
First PostedJan 24, 2014
Enrollment StartJan 1, 2014
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.4 years ago
Interventions
Dabigatran etexilatedrug
Pellets (multiple dose of dabigatran)
Dabigatran etexilatedrug
Granules resolved in reconstitution solution (multiple dose of dabigatran)
Dabigatran etexilatedrug
Hard capsule (multiple dose of dabigatran)