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OpenTrials
Completed

NCT Number: NCT01595854

Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran

Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods

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

1160.141.1 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

medium dose dabigatran

Ticagrelor

Drug

high dose ticagrelor

Primary outcomes

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

    Time frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

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

  2. Total Dabigatran: Maximum Measured Concentration (Cmax)

    Time frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

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

Secondary outcomes

  1. Number of Participants With Drug Related Adverse Events

    Time frame: From screening until the end-of-study examination

    The number of participants with drug related adverse events

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 10, 2012
Registry last updated
Aug 22, 2013

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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