A Phase 1 interventional study of Dabigatran and Rabeprazole and Dabigatran in Healthy, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-25.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 1 and Interventional
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.
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Period " Dabigatran" * Washout period (at least 6 days) * Period " Rabeprazole + Dabigatran" * Washout period (at least 6 days) * Period " Omeprazole + Dabigatran"
Drug: Dabigatran · Drug: Rabeprazole and Dabigatran · Drug: Omeprazole and Dabigatran
* Period "Rabeprazole + Dabigatran " * Washout period (at least 6 days) * Period " Dabigatran" * Washout period (at least 6 days) * Period " Omeprazole + Dabigatran"
Drug: Dabigatran · Drug: Rabeprazole and Dabigatran · Drug: Omeprazole and Dabigatran
* Period " Rabeprazole + Dabigatran" * Period " Omeprazole + Dabigatran" * Period " Dabigatran"
Drug: Dabigatran · Drug: Rabeprazole and Dabigatran · Drug: Omeprazole and Dabigatran
dabigatran etexilate 150 mg/day (1 day)
rabeprazole 20 mg / day for 5 days, then the 6th day concomitant rabeprazole 20 mg of dabigatran etexilate 150 mg;
omeprazole 20 mg / day for 5 days, then the sixth day concomitant omeprazole 20 mg and 150 mg dabigatran etexilate
Area under the curve (AUC) from plasma concentrations of dabigatran
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: baseline after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 0.25 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 0.5 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 1 hour after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 1.5 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 2 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 3 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 6 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 8 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 12 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 24 hours after each dose of dabigatran etexilate.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne