drugset / Trial / NCT02524210

Effect of Inhibitors of the Proton Pump on Intestinal Transporters

NCT02524210

Phase 1 Completed 12 enrolled University Hospital of Saint-Etienne
RandomizedFactorialSingle-blind

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.

Timeline

Start
2014-05
Primary completion
2015-05
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran Unknown 150 mg Oral
Subject Omeprazole Other / unclassified 20 mg
Subject Rabeprazole Small molecule 20 mg

Indications

No indication recorded.