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Completed

NCT Number: NCT01306162

Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1160.112.1 Boehringer Ingelheim Investigational Site

Ulm, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

Dabigatran etexilate plus dronedarone

Drug

dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose

Dabigatran Etexilate

Drug

150 mg as single dose

Primary outcomes

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

    Time frame: 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

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

  2. Total Dabigatran: Maximum Measured Concentration (Cmax)

    Time frame: 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

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

Secondary outcomes

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

    Time frame: 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

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

  2. Free Dabigatran: Maximum Measured Concentration (Cmax)

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
First posted
Mar 1, 2011
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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