At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Relative Bioavailability of a Single Dose of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Dronedarone Tablet) or in Combination With 400 mg Bid Dronedarone (Tablet) at Steady State in Healthy Male and Female Volunteers (an Open Label, Randomised, Four-sequence, Two Period Cross-over, Phase I Study)
In Brief
A Phase 1 clinical trial evaluating Dabigatran etexilate plus dronedarone and Dabigatran etexilate for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to healthy subjects
Study Details
Timeline
Interventions
dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose
150 mg as single dose
dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration)
dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid
dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)