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NOT YET RECRUITING
NCT07632274
PHASE1

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

Sponsor: HALEON

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-06

Completion Date

2026-09

Last Updated

2026-06-08

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Test Product

Liquid suspension FDC IBU 62.5 mg / APAP 125 mg

Locations (1)

CenExel Salt Lake

Salt Lake City, Utah, United States