Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects

Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects : RICHAR Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02657512

Acronym

RICHAR

Enrollment

Registered

2016-01-18

Start date

2016-01-31

Completion date

2016-04-30

Last updated

2016-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Rivaroxaban, pharmacokinetics, activated charcoal, 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. Few results are available on the use of activated charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to apixaban (a direct oral anticoagulant of the same class). The objective of this study is to evaluate the effect of 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 alone and rivaroxaban with activated charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.

Interventions

DRUGrivaroxaban

rivaroxaban 40 mg/day (1 day)

DRUGrivaroxaban and activated charcoal

rivaroxaban 40 mg/day (1 day) and 50 g of activated charcoal 2 or 5 or 8 hours after rivaroxaban administration (1 day)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

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 genetic consent form * BMI between 18.5 and 25 * normal clinical exam * normal biological exam

Exclusion criteria

* contra-indication to rivaroxaban * contra-indication to activated charcoal * previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease smoker * Organic lesion likely to bleed * severe liver disease * severe kidney failure * previous surgery within one month

Design outcomes

Primary

Measure	Time frame	Description
plasma concentrations of rivaroxaban	H0.5, H0.75, H1, H1.5, H2, H2.5, H3, H4, H5, H6, H8, H10, H12, H14, H18 and H24 after rivaroxaban administration	rivaroxaban pharmacokinetics

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026