Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

• Status: Completed
• Trial end date: 2019-07-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Treatments: Ibuprofen

Criteria

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.