Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.
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.
Timeline
- Start
- 2022-01-03
- Primary completion
- 2022-09-26
- Completion
- 2022-11-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Activated Charcoal | Other / unclassified | 6 g | — |
| Subject | Activated Charcoal | Other / unclassified | 12 g | — |
| Subject | Activated Charcoal | Other / unclassified | 24 g | — |
| Subject | Activated Charcoal | Other / unclassified | 50 g | — |
| Subject | Rivaroxaban | Other / unclassified | 40 mg | Oral |
Indications
No indication recorded.