At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Dabigatran Etexilate +1 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 Tablet Formulation of Dabigatran Etexilate With and Without Co-administration of Rabeprazole in Healthy Male Subjects (an Open-label, Single-dose, Two-period, Single-arm Study)
In Brief
A Phase 1 clinical trial evaluating Dabigatran Etexilate and Rabeprazol sodium for Non-alcoholic Fatty Liver Disease. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the relative Bioavailability (BA) of tablet formulation of Dabigatran etexilate (DE) with and without co-administration of rabeprazole in healthy male subjects. The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-alcoholic Fatty Liver Disease
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartMay 2017
Primary CompletionJul 2017
Study CompletionAug 2017
TodayJul 2026
First PostedMay 8, 2017
Enrollment StartMay 22, 2017
Primary CompletionJul 27, 2017
Study CompletionAug 2, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.2 years ago
Interventions
Dabigatran Etexilatedrug
Tablet, film coated
Rabeprazol sodiumdrug
Tablet