Effect of Inhibitors of the Proton Pump on Intestinal Transporters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm A

* Period " Dabigatran"
* Washout period (at least 6 days)
* Period " Rabeprazole + Dabigatran"
* Washout period (at least 6 days)
* Period " Omeprazole + Dabigatran"

Group Type EXPERIMENTAL

Dabigatran

Intervention Type DRUG

dabigatran etexilate 150 mg/day (1 day)

Rabeprazole and Dabigatran

Intervention Type DRUG

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

Omeprazole and Dabigatran

Intervention Type DRUG

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

Arm B

* Period "Rabeprazole + Dabigatran "
* Washout period (at least 6 days)
* Period " Dabigatran"
* Washout period (at least 6 days)
* Period " Omeprazole + Dabigatran"

Group Type EXPERIMENTAL

Dabigatran

Intervention Type DRUG

dabigatran etexilate 150 mg/day (1 day)

Rabeprazole and Dabigatran

Intervention Type DRUG

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

Omeprazole and Dabigatran

Intervention Type DRUG

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

Arm C

* Period " Rabeprazole + Dabigatran"
* Period " Omeprazole + Dabigatran"
* Period " Dabigatran"

Group Type EXPERIMENTAL

Dabigatran

Intervention Type DRUG

dabigatran etexilate 150 mg/day (1 day)

Rabeprazole and Dabigatran

Intervention Type DRUG

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

Omeprazole and Dabigatran

Intervention Type DRUG

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

Interventions

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Dabigatran

dabigatran etexilate 150 mg/day (1 day)

Intervention Type DRUG

Rabeprazole and Dabigatran

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

Intervention Type DRUG

Omeprazole and Dabigatran

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes