Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01306162
First received: February 28, 2011
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Dabigatran etexilate plus dronedarone Drug: Dabigatran etexilate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Drug Information available for:
Dronedarone
Dabigatran
Dabigatran etexilate
Dabigatran etexilate mesylate
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 day ] [ Designated as safety issue: No ]Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.
- Total Dabigatran: Maximum Measured Concentration (Cmax) [ Time Frame: 1 day ] [ Designated as safety issue: No ]Maximum measured concentration of total dabigatran in plasma, per period.
Secondary Outcome Measures:
- Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 day ] [ Designated as safety issue: No ]Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.
- Free Dabigatran: Maximum Measured Concentration (Cmax) [ Time Frame: 1 day ] [ Designated as safety issue: No ]Maximum measured concentration of free dabigatran in plasma, per period.
| Enrollment: | 36 |
| Study Start Date: | February 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A: Dabigatran alone (Reference)
Capsule, oral administration with 240 mL water
|
Drug: Dabigatran etexilate
150 mg as single dose
|
|
Experimental: B: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
|
Drug: Dabigatran etexilate plus dronedarone
dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose
|
|
Experimental: C: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
|
Drug: Dabigatran etexilate plus dronedarone
dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration)
|
|
Experimental: D: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
|
Drug: Dabigatran etexilate plus dronedarone
dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid
|
|
Experimental: E: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
|
Drug: Dabigatran etexilate plus dronedarone
dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
1. Healthy male and female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306162
Locations
| Germany | |
| 1160.112.1 Boehringer Ingelheim Investigational Site | |
| Ulm, Germany | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01306162 History of Changes |
| Other Study ID Numbers: | 1160.112, 2010-024009-11 |
| Study First Received: | February 28, 2011 |
| Results First Received: | May 23, 2012 |
| Last Updated: | June 29, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Amiodarone Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents |
ClinicalTrials.gov processed this record on May 22, 2013