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OpenTrials
Completed

NCT Number: NCT01734772

Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

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)

Completed

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1160.142.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects.

Exclusion criteria

  • Any relevant deviation from healthy conditions.

Treatment and study plan

Dabigatran Etexilate

Drug

multiple doses of dabigatran

Ticagrelor

Drug

loading dose of ticagrelor

Primary outcomes

  1. Total Dabigatran: Area Under the Concentration-time Curve 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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2012
Registry last updated
May 5, 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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