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

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.

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.

Inclusion Criteria:

• Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and < six (6) months of age.
• Have a clinical indication of pain or fever.
• Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or performance of any study-only related procedures.

Exclusion Criteria:

• Have inadequate intravenous access.
• Have an uncorrected ductus dependent congenital heart disease.
• Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory drug or aspirin.
• Have a current history of uncorrected hypovolemia or acute renal disease.
• Have a current history of acute liver disease.
• Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to dosing. Have received another investigational drug within the past 30 days.
• Be otherwise unsuitable for the study, in the opinion of the Investigator.