Ibuprofen + Acetaminophen for Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for children aged 6 to 11 years, weighing between 48-95 lbs, who have mild pain or low-grade fever from things like dental work, minor injuries, or recent vaccinations. Participants should be generally healthy and able to follow study instructions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of the fixed-dose combination product after an overnight fast
Follow-up
Participants are monitored for pharmacokinetic parameters through blood sampling at specified time points
What Are the Treatments Tested in This Trial?
Trial Overview
The study is testing a liquid medicine that combines ibuprofen (62.5 mg) and acetaminophen (125 mg) per 5 mL dose in kids ages 6–11. The goal is to see how the body processes this combination when given by mouth.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive a single dose (weight-based) of Test Product orally using 10 mL oral dosing syringes followed by 4 ounce (oz) ambient temperature water.
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Who Is Running the Clinical Trial?
HALEON
Lead Sponsor
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