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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004425-25 | EudraCT Number |
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Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. A recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to rivaroxaban. However, no results are available on the minimal dose of activated charcoal necessary in rivaroxaban poisoning. The objective of this study is to evaluate the effect of 4 dosing regimen activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban with 50g, 24g, 12g and 6g of activated charcoal administrated 3 hours after rivaroxaban intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
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| Arm B | Experimental |
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| Arm C | Experimental |
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| Arm D | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | rivaroxaban 40 mg/day (1 day). |
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| Measure | Description | Time Frame |
|---|---|---|
| plasma concentrations of rivaroxaban | rivaroxaban pharmacokinetics | 1, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24 hours after rivaroxaban administration |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Analysis adverse events related to the administration of treatment. | 24 hour after rivaroxaban administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick MISMETTI, MD PhD | CHU de SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de SAINT-ETIENNE | Saint-Etienne | 42000 | France |
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| ID | Term |
|---|---|
| D000881 | Anthrax |
| D011041 | Poisoning |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Activated charcoal | Drug | Activated charcoal 2 hours after rivaroxaban administration (1 day). |
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| D007239 | Infections |
| D064419 | Chemically-Induced Disorders |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |