drugset / Trial / NCT02524210
Effect of Inhibitors of the Proton Pump on Intestinal Transporters
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabigatran | Unknown | 150 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
| Subject | Rabeprazole | Small molecule | 20 mg | — |
Indications
No indication recorded.