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A Study on the Impact of Rabeprazole-induced Elevated Stomach pH on APO-Dabigatran Exposure in Healthy Volunteers

NCT04157881 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-03-21

No results posted yet for this study

Summary

Open-label, crossover study recruiting 46 healthy male volunteers comparing the absorption of APO-dabigatran 150 mg per oral (PO) in the absence or presence of a proton pump inhibitor. Participants will serve as their own control when comparing dabigatran exposure in the absence or presence of the proton pump inhibitor, Rabeprazole 20 mg.

Conditions

Interventions

DRUG

RABEprazole 20 Mg Oral Delayed Release Tablet

Absorption of APO-Dabigatran measured with and without influence of rabeprazole

DRUG

APO-Dabigatran 150mg

Absorption of APO-Dabigatran post single dose

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • John Eikelboom, MBBS, MSc · Population Health Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2022-01-18
Completion
2022-01-18

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04157881 on ClinicalTrials.gov