Phase 1
N=36
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01306162 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞) — 1160; 2520; 1440; 2570 ng*hr/mL — p=1.0000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Dabigatran etexilate plus dronedarone (Drug); Dabigatran etexilate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞) |
1160; 2520; 1440; 2570; 1510 | 1.0000 |
| PRIMARY Total Dabigatran: Maximum Measured Concentration (Cmax) |
149; 282; 166; 288; 163 | 0.9999 |
| SECONDARY Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞) |
919; 2110; 1110; 2100; 1260 | 1.0000 |
| SECONDARY Free Dabigatran: Maximum Measured Concentration (Cmax) |
126; 239; 133; 241; 138 | 0.9998 |
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
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01306162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.