Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

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.