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

Phase 1CompletedNCT01595854

Boehringer Ingelheim36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

medium dose dabigatran

high dose ticagrelor

high dose ticagrelor

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

Medical Language ↔ Plain English

Inclusion criteria: 1. Healthy male subjects Exclusion criteria: 2. Any relevant deviation from healthy conditions

1160.141.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

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

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

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

Total Dabigatran: Maximum Measured Concentration (Cmax)

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

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

Number of Participants With Drug Related Adverse Events

The number of participants with drug related adverse events

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

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