Trials / Completed
CompletedNCT02583399
Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Cumberland Pharmaceuticals · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibuprofen | Ibuprofen, 10 mg/kg |
Timeline
- Start date
- 2017-08-08
- Primary completion
- 2019-07-02
- Completion
- 2019-07-02
- First posted
- 2015-10-22
- Last updated
- 2020-11-20
- Results posted
- 2020-11-20
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02583399. Inclusion in this directory is not an endorsement.