Dabigatran does not prolong the QT interval with supratherapeutic exposure: a thorough QT study in healthy subjects.

ABSTRACT:

Background

Dabigatran etexilate is a pro-drug of the oral reversible direct thrombin inhibitor dabigatran that interacts with the active site in the catalytic domain of the thrombin molecule.

Objective

To assess the electrophysiological effects of therapeutic and supratherapeutic doses of dabigatran etexilate in healthy subjects, a thorough QT study was performed.

Methods

In this single-centre, blinded, placebo- and active-controlled, four-period, crossover study, 40 healthy Caucasian subjects (20 women and 20 men) received single oral doses of dabigatran etexilate (150 mg and 600 mg), moxifloxacin 400 mg (positive control) or placebo, in a randomized order. Electrocardiogram (ECG) profiles were recorded at baseline and during the randomized study treatment in each pe

SUBMITTER: Ring A 

PROVIDER: S-EPMC3634983 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature