Status:
COMPLETED
Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
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 poison...
Eligibility Criteria
Inclusion
- 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
- 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 ...)
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04767776
Start Date
January 3 2022
End Date
November 4 2022
Last Update
December 5 2022
Active Locations (1)
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1
CHU de SAINT-ETIENNE
Saint-Etienne, France, 42000