Effect of Inhibitors of the Proton Pump on Intestinal Transporters

Effect of Inhibitors of the Proton Pump on Intestinal Transporters and Their Impact on the Pharmacokinetics of Dabigatran - Mechanistic and Clinical Approach -BIPP Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02524210

Acronym

BIPP

Enrollment

Registered

2015-08-14

Start date

2014-05-31

Completion date

2015-12-31

Last updated

2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

volunteers

Brief summary

Dabigatran etexilate is a novel oral anticoagulant. It is indicated in venous thromboembolic prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as anticoagulants in preventing thromboembolism in atrial fibrillation. However, it increases the risk of gastrointestinal bleeding compared to standard treatment (AVK) \[3\]. In these circumstances the risk / benefit of dabigatran could be improved by combining it with gastric protectors such as inhibitor drugs proton pump (IPP). Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of co-administration of these two IPP (omeprazole, rabeprazole) with dabigatran in healthy subjects.

Interventions

DRUGDabigatran

dabigatran etexilate 150 mg/day (1 day)

DRUGRabeprazole and Dabigatran

rabeprazole 20 mg / day for 5 days, then the 6th day concomitant rabeprazole 20 mg of dabigatran etexilate 150 mg;

DRUGOmeprazole and Dabigatran

omeprazole 20 mg / day for 5 days, then the sixth day concomitant omeprazole 20 mg and 150 mg dabigatran etexilate

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* weight between 60 and 85 kg * normal clinical exam * normal biological exam

Exclusion criteria

* hypersensitivity to dabigatran or any of its excipients * hypersensitivity to omeprazole or rabeprazole or any of its excipients * previous history of hemorrhagic disease * insufficiency liver * severe kidney failure * peptic ulcer * Any drug taken during the week before the start of the study * smoker * Consumption of grapefruit juice * practice of violent sport

Design outcomes

Primary

Measure	Time frame	Description
Area under the curve (AUC) from plasma concentrations of dabigatran	baseline after each dose of dabigatran etexilate.	Area under the curve (AUC) from plasma concentrations of dabigatran

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026