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.
