At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 180 enrolled
Drug / intervention
Dabigatran etexilate +1 moredrug
Likely dose
Dabigatran etexilate 150 mgfrom 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 Two Different Capsule Types of 150 mg Dabigatran Etexilate Made From Two Different Drug Product Batches, Following Oral Administration in Healthy Male and Female Volunteers (Open-label, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Study)
In Brief
A Phase 1 clinical trial evaluating Dabigatran etexilate for Healthy. Completed, enrolled 180 participants across 1 site.
Detailed Summary
The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches. The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using a new capsule shell (Capsugel). The test batch is the drug product intended for future commercial use.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedFeb 2011
Primary CompletionApr 2011
TodayJul 2026
First PostedFeb 7, 2011
Enrollment StartJan 1, 2011
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.4 years ago
Interventions
Dabigatran etexilatedrug
150 mg Capsugel (T)
Dabigatran etexilatedrug
150 mg Qualicaps (R)