Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

Boehringer Ingelheim36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Dabigatran etexilate plus dronedaroneDRUG

dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose

Dabigatran etexilateDRUG

150 mg as single dose

Dabigatran etexilate plus dronedaroneDRUG

dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1\. Healthy male and female subjects Exclusion criteria: 1\. Any relevant deviation from healthy conditions

Locations (1)

1160.112.1 Boehringer Ingelheim Investigational Site

Ulm, Germany

Outcomes

Primary Outcomes

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.

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

Total Dabigatran: Maximum Measured Concentration (Cmax)

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

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

Secondary Outcomes

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

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

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

Free Dabigatran: Maximum Measured Concentration (Cmax)

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

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

Data from ClinicalTrials.gov

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