At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 160 enrolled
Drug / intervention
dabigatran etexilatedrug
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.
Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Replicate Design in a Two-treatment, Four-period, Two-sequence Crossover Study)
In Brief
A Phase 1 clinical trial evaluating dabigatran etexilate for Healthy. Completed, enrolled 160 participants across 1 site.
Detailed Summary
The primary objective of this trial is to establish the bioequivalence of tablet formulation of dabigatran etexilate compared to commercial capsule formulation following oral administration under fasted condition. The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartMar 2017
Primary CompletionJun 2017
Study CompletionJun 2017
TodayJul 2026
First PostedMar 3, 2017
Enrollment StartMar 21, 2017
Primary CompletionJun 16, 2017
Study CompletionJun 20, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.3 years ago
Interventions
dabigatran etexilatedrug
single dose