Effect of Inhibitors of the Proton Pump on Intestinal Transporters (BIPP)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dabigatran; Drug: Omeprazole and Dabigatran; Drug: Rabeprazole and Dabigatran

Study type: Interventional

Funder types: Other

Identifiers

NCT02524210

140096A-21 (Other Identifier)

1208088

2013-004932-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 3 patient groups

Arm A

Experimental group

Description:

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

Treatment:

Drug: Omeprazole and Dabigatran

Drug: Rabeprazole and Dabigatran

Drug: Dabigatran

Arm B

Experimental group

Description:

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

Treatment:

Drug: Omeprazole and Dabigatran

Drug: Rabeprazole and Dabigatran

Drug: Dabigatran

Arm C

Experimental group

Description:

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

Treatment:

Drug: Omeprazole and Dabigatran

Drug: Rabeprazole and Dabigatran

Drug: Dabigatran