Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Phase 4 Completed 30 enrolled Cumberland Pharmaceuticals

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2017-08-08
Primary completion: 2019-07-02
Completion: 2019-07-02

Publications

Glover CD, Berkenbosch JW, Taylor MB, Patel NV, Kaelin B, Gibson BHY, Zhong J. A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age. Paediatr Drugs. 2023 Sep;25(5):585-593. doi: 10.1007/s40272-023-00576-9. Epub 2023 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibuprofen	Small molecule	10 mg/kg	Intravenous

Indications

No indication recorded.