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Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children

NCT02497716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-04-16

No results posted yet for this study

Summary

To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability

Conditions

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939

Single dose of reconstituted rivaroxaban granules

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-04
Primary Completion
2018-05-22
Completion
2018-05-22
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Finland
  • France
  • Hungary
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02497716 on ClinicalTrials.gov