A Phase I, Single-Center, Open-Label, Single-Dose, Pharmacokinetic Study to Evaluate Ibuprofen (IBU) 62.5 mg and Acetaminophen (APAP) 125 mg/5 ml in an Oral Liquid Suspension Fixed-Dose Combination Product in Children Aged 6 to 11 Years
HALEON
Summary
The purpose of this study will be to characterize the pharmacokinetic (PK) profile of the Fixed-Dose Combination (FDC) IBU 62.5 milligram (mg)/APAP 125 mg per 5 milliliter (mL) suspension in children 6 to 11 years of age, inclusive, to satisfy Pediatric Research Equity Act (PREA) requirements.
Description
This will be a single-center, open-label PK study to assess the pharmacokinetic profile of IBU and APAP from a single oral dose of FDC IBU 62.5 mg/APAP 125 mg per 5 mL liquid suspension in children. Following an overnight fast of at least 8 hours, participants will receive a low-fat breakfast approximately 2.5 hours prior to dosing. The study will enroll approximately 12 children between the ages of 6 and 11 years, inclusive, with the goal of ensuring that at least 10 evaluable participants complete the study.
Eligibility
- Age range
- 6–11 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants meeting at least one of the following criteria: 1. Participant with at least one acute, painful condition (e.g., minor aches and pains due to headache, menstruation, toothache, sports injuries, etc.) requiring use of an oral over the counter (OTC) analgesic within the previous 4 weeks (but not within the 48 hours prior to Day 1, Hour 0 investigational product dosing). 2. Participant has undergone a non-surgical orthodontic or dental procedure (e.g., placement of an orthodontic appliance or adjustment of braces) within 24 hours prior to dosing. 3. Part…
Interventions
- DrugTest Product
Liquid suspension FDC IBU 62.5 mg / APAP 125 mg
Location
- CenExel Salt LakeSalt Lake City, Utah