A 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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
HALEON
Study ID
NCT07632274
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Accepted

Interventions

  • Test Product — DRUG
    Liquid suspension FDC IBU 62.5 mg / APAP 125 mg

Study Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
Jun 19, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Test Product
    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.

Primary Outcome Measure

Area Under the Plasma Concentration Versus (Vs.) Time Curve Calculated from Time 0 to the Last Measurable Sampling Time Point (AUC0-t) for Ibuprofen and Acetaminophen [ Time Frame: Pre-dose (within 1 hour prior to dosing) and at 5, 15, 30 minutes and 1 ,1.25, 1.5, 2, 4, 6, 9, 12 hours post dose on Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CenExel Salt LakeSalt Lake CityUtah84107
Todd Bertouch, MD

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CenExel Salt Lake· Salt Lake City, UT

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