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

Recruiting Phase 1 Interventional Study
Pain
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
6 – 11
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
12 (estimated)
Sponsor
HALEON · Industry
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About 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.

Trial Locations
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Eligibility Criteria
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 wit…
Contacts

Haleon Response Center

+441932959500

ww.clinical-trial-register@haleon.com

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