Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004932-31 | EudraCT Number | ||
| 140096A-21 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
|
|
| Arm B | Experimental |
|
|
| Arm C | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug | dabigatran etexilate 150 mg/day (1 day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) from plasma concentrations of dabigatran | Area under the curve (AUC) from plasma concentrations of dabigatran | baseline after each dose of dabigatran etexilate. |
| Area under the curve (AUC) from plasma concentrations of dabigatran | 0.25 hours after each dose of dabigatran etexilate. | |
| Area under the curve (AUC) from plasma concentrations of dabigatran | 0.5 hours after each dose of dabigatran etexilate. | |
| Area under the curve (AUC) from plasma concentrations of dabigatran | 1 hour after each dose of dabigatran etexilate. | |
| Area under the curve (AUC) from plasma concentrations of dabigatran | 1.5 hours after each dose of dabigatran etexilate. | |
| Area under the curve (AUC) from plasma concentrations of dabigatran | 2 hours after each dose of dabigatran etexilate. | |
| Area under the curve (AUC) from plasma concentrations of dabigatran | 3 hours after each dose of dabigatran etexilate. | |
| Area under the curve (AUC) from plasma concentrations of dabigatran | 6 hours after each dose of dabigatran etexilate. | |
| Area under the curve (AUC) from plasma concentrations of dabigatran |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laurent BERTOLETTI, MD PhD | CHU de SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de SAINT-ETIENNE | Saint-Etienne | 42000 | France |
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D064750 | Rabeprazole |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rabeprazole and Dabigatran | Drug | rabeprazole 20 mg / day for 5 days, then the 6th day concomitant rabeprazole 20 mg of dabigatran etexilate 150 mg; |
|
| Omeprazole and Dabigatran | Drug | omeprazole 20 mg / day for 5 days, then the sixth day concomitant omeprazole 20 mg and 150 mg dabigatran etexilate |
|
| 8 hours after each dose of dabigatran etexilate. |
| Area under the curve (AUC) from plasma concentrations of dabigatran | 12 hours after each dose of dabigatran etexilate. |
| Area under the curve (AUC) from plasma concentrations of dabigatran | 24 hours after each dose of dabigatran etexilate. |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |