At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Dabigatran etexilate pellets +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 Application Forms of a Single Oral Dose of 150 mg Dabigatran Etexilate (Capsule, Powder for Reconstitution Into Solution, Pellets on Food) in Healthy Male and Female Volunteers (an Open-label, Randomised, Three-way Crossover, Clinical Phase I Study)
In Brief
A Phase 1 clinical trial evaluating Dabigatran etexilate pellets, Dabigatran etexilate powder, and 1 other intervention for Healthy. Completed, enrolled 30 participants.
Detailed Summary
To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution, both with 150 mg of dabigatran etexilate as capsule in healthy volunteers
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
Primary CompletionMay 2009
First PostedJun 2014
TodayJul 2026
First PostedJun 24, 2014
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.0 years ago
Interventions
Dabigatran etexilate pelletsdrug
Dabigatran etexilate powderdrug
Dabigatran etexilate capsuledrug