Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
- Registration Number
- NCT02583399
- Lead Sponsor
- Cumberland Pharmaceuticals
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ibuprofen Ibuprofen Ibuprofen, 10 mg/kg
- Primary Outcome Measures
Name Time Method Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. 4 hours This outcome measurement was to the determine the area under the plot of plasma concentrations of drug against time after drug administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. 4 hours This outcome measurement was to measure the maximal or peak measured serum concentration (Cmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. 4 hours This outcome measurement was to determine the half-life or the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. 4 hours This outcome measurement was to determine the time to maximum concentration (Tmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Baylor College of Medicine/Texas Children's Hospital
🇺🇸Houston, Texas, United States
Kosair Charaties Pediatric Research Unit
🇺🇸Louisville, Kentucky, United States