Trials / Completed
CompletedNCT02497716
Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children
Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 2 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban (Xarelto, BAY59-7939 | Single dose of reconstituted rivaroxaban granules |
Timeline
- Start date
- 2015-11-04
- Primary completion
- 2018-05-22
- Completion
- 2018-05-22
- First posted
- 2015-07-14
- Last updated
- 2019-04-16
Locations
21 sites across 8 countries: United States, Belgium, Canada, Finland, France, Hungary, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02497716. Inclusion in this directory is not an endorsement.