Effect of Inhibitors of the Proton Pump on Intestinal Transporters

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Treatments: Dabigatran; Omeprazole; Rabeprazole

Criteria

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