drugset / Trial / NCT01464450

Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants

NCT01464450

Phase 1 Completed 55 enrolled Janssen Scientific Affairs, LLC Bayer · collab
RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of this study is to learn about the relative bioavailability (the extent to which the drug becomes available to the body) and pharmacokinetics (blood levels) of rivaroxaban in healthy participants after receiving a 20 mg rivaroxaban tablet orally as a whole tablet, crushed and mixed in applesauce, and as a suspension through a Naso-gastric (NG) tube. The relative bioavailability of rivaroxaban may be different when given as a crushed tablet compared with an intact (whole) tablet and when given via an NG tube. The safety and tolerability of rivaroxaban will also be assessed.

Timeline

Start
2011-10
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rivaroxaban Other / unclassified 20 mg Oral

Indications

No indication recorded.