Healthy
Conditions
Keywords
Rivaroxaban,, Activated charcoal, Pharmacokinetics, Poisoning
Brief summary
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.
Interventions
DRUGRivaroxaban
rivaroxaban 40 mg/day (1 day).
Activated charcoal 2 hours after rivaroxaban administration (1 day).
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Affiliated or beneficiary of a social security category * Having signed the inform consent form * Having signed the biologic consent form * Men aged between 18 and 40 years * Weight between 55 and 92 kilogram * normal clinical exam * normal biological exam
Exclusion criteria
* Contra-indication to rivaroxaban * Contra-indication to activated charcoal * With a history of hemorrhagic disease * Smoker * Organic lesion likely to bleed * Severe liver disease * Severe kidney failure * Gastroduodenal ulcers * Any medication taken during the week prior to the start of the study * Consumption of grapefruit juice * Routine ingestion of excessive amounts of coffee, tea, chocolate and/or caffeinated beverages * Practice of violent sports * Fructose intolerance * Glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency syndrome * Notable medical history (cardiovascular pathology, pulmonary, neurology ...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma concentrations of rivaroxaban | 1, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24 hours after rivaroxaban administration | rivaroxaban pharmacokinetics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 24 hour after rivaroxaban administration | Analysis adverse events related to the administration of treatment. |
Countries
France
Outcome results
None listed