NCT01306162

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 14, 2012

Completed
Last Updated

June 6, 2014

Status Verified

April 1, 2014

Enrollment Period

3 months

First QC Date

February 28, 2011

Results QC Date

May 23, 2012

Last Update Submit

June 3, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)

    Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.

    1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

  • Total Dabigatran: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of total dabigatran in plasma, per period.

    1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

Secondary Outcomes (2)

  • Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)

    1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

  • Free Dabigatran: Maximum Measured Concentration (Cmax)

    1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

Study Arms (5)

A: Dabigatran alone (Reference)

EXPERIMENTAL

Capsule, oral administration with 240 mL water

Drug: Dabigatran etexilate

B: Dabigatran plus Dronedarone (Test)

EXPERIMENTAL

Capsule and Tablets, oral administration with 240 mL water

Drug: Dabigatran etexilate plus dronedarone

C: Dabigatran plus Dronedarone (Test)

EXPERIMENTAL

Capsule and Tablets, oral administration with 240 mL water

Drug: Dabigatran etexilate plus dronedarone

D: Dabigatran plus Dronedarone (Test)

EXPERIMENTAL

Capsule and Tablets, oral administration with 240 mL water

Drug: Dabigatran etexilate plus dronedarone

E: Dabigatran plus Dronedarone (Test)

EXPERIMENTAL

Capsule and Tablets, oral administration with 240 mL water

Drug: Dabigatran etexilate plus dronedarone

Interventions

Dabigatran etexilate plus dronedaroneDRUG

dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose

B: Dabigatran plus Dronedarone (Test)
Dabigatran etexilateDRUG

150 mg as single dose

A: Dabigatran alone (Reference)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Healthy male and female subjects

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1160.112.1 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

MeSH Terms

Interventions

DabigatranDronedarone

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAmiodaroneBenzofurans

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 1, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Last Updated

June 6, 2014

Results First Posted

August 14, 2012

Record last verified: 2014-04

Locations

DE(1)