Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

NCT01734772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-05-05

Study results available
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Summary

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)

Conditions

  • Healthy

Interventions

DRUG

dabigatran etexilate

multiple doses of dabigatran

DRUG

dabigatran etexilate

medium dose dabigatran

DRUG

ticagrelor

loading dose of ticagrelor

DRUG

ticagrelor

multiple doses of ticagrelor

DRUG

ticagrelor

loading dose of ticagrelor

DRUG

dabigatran etexilate

single dose of dabigatran

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01734772 on ClinicalTrials.gov