Impact of Rabeprazole on APO-Dabigatran Exposure in Healthy Volunteers.

ABSTRACT:

Background

Dabigatran is effective and safe for stroke prevention in patients with atrial fibrillation and for venous thromboembolism prevention and treatment. In Canada, APO-dabigatran, a generic formulation, has been approved based on a bioequivalence study, but its bioavailability in settings of reduced gastric acidity has not been examined.

Methods

Treatment With APO-Dabigatran Absorption (TADA) was an open-label crossover study in 46 healthy male volunteers, comparing the absorption of APO-dabigatran (150 mg) with vs without rabeprazole. The primary outcome was the 24-hour total dabigatran exposure as measured by area under the curve (AUC) and peak concentration (C_max).

Results

Compared with no rabeprazole pretreatment, the total d

SUBMITTER: Chan N 

PROVIDER: S-EPMC9869351 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature