Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

Boehringer Ingelheim48 enrolled

Overview

To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

dabigatran etexilateDRUG

multiple doses of dabigatran

dabigatran etexilateDRUG

medium dose dabigatran

ticagrelorDRUG

loading dose of ticagrelor

ticagrelor

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

1160.142.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).

Time frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours

Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)

Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).

Time frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours

Data from ClinicalTrials.gov

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