The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.
| Study Type: |
Interventional (Clinical Trial) |
| Estimated Enrollment: |
24 participants |
| Allocation: |
Single Group Assignment |
| Intervention Model: |
Multi-center, Open-label |
| Masking: |
None (Open Label) |
| Primary Purpose: |
Treatment |
| Official Title: |
A Multi-Center, Open-Label Pharmacokinetic and Safety Study for Reduction in Fever or Management of Pain in Pediatric Subjects Aged Birth to Six Months |
| Actual Study Start Date: |
July 17, 2017 |
| Estimated Primary Completion Date: |
December 2018 |
| Estimated Study Completion Date: |
December 2018 |
Contact
| Contact: Byron Kaelin |
615-255-0068 ext 250 |
bkaelin@cumberlandpharma.com |
| Contact: Jerry Fox |
615-255-0068 ext 226 |
jfox@cumberlandpharma.com |
| ClinicalTrials.gov Identifier: |
NCT02583399 |
For enrollment please visit
www.clinicaltrials.gov.
