At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
Dabigatran etexilate tablet E1 +5 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 Single Oral Administration of Five Different Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Six-period, Five-sequence Crossover Study)
In Brief
A Phase 1 clinical trial evaluating Dabigatran etexilate tablet E1, Dabigatran etexilate tablet D1, and 4 other interventions for Healthy. Completed, enrolled 35 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the relative bioavailability of five different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1, Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule formulation of Dabigatran Etexilate. The secondary objective is to evaluate and compare several pharmacokinetic parameters between the treatments.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartMar 2016
Primary CompletionMay 2016
Study CompletionJun 2016
TodayJul 2026
First PostedMar 17, 2016
Enrollment StartMar 22, 2016
Primary CompletionMay 11, 2016
Study CompletionJun 10, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.3 years ago
Interventions
Dabigatran etexilate tablet E1drug
Dabigatran etexilate tablet D1drug
Dabigatran etexilate tablet C1drug
Dabigatran etexilate tablet B1drug
Dabigatran etexilate tablet A1drug
Dabigatran etexilate capsuledrug