What is this study trying to find out about pain in children?

This study aims to understand how ibuprofen and acetaminophen from a combined liquid medicine behave in children aged 6 to 11 years. Researchers want to see how the body absorbs, processes, and clears these drugs to meet important pediatric research standards. The sponsor conducting this research is HALEON.

Who may be eligible for this pain clinical trial in children?

Children aged 6 to 11 years with acute pain conditions, recent dental or orthodontic procedures, or low-grade fever after vaccination may be eligible. They must be generally healthy, weigh between 48 and 95 pounds, and able to follow study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this pain clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 6Years - 11Years

All Genders

Healthy Volunteers

ID07632274

Study of Ibuprofen 62.5 mg and Acetaminophen 125 mg Oral Suspension in Children Ages 6 to 11 Years to Understand How the Medicines Work in the Body

Led by HALEON · Updated on 2026-06-30

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the pharmacokinetic profile of a fixed-dose combination oral liquid suspension containing ibuprofen 62.5 mg and acetaminophen 125 mg per 5 mL in children aged 6 to 11 years. This study aims to meet Pediatric Research Equity Act requirements by understanding how these medicines behave in the bodies of children within this age group. The study is a phase 1, open-label, single-center trial focusing on children with certain pain conditions or post-procedure pain. Participants will receive a single weight-based dose of the study product orally using a dosing syringe, followed by water. Before dosing, children will fast overnight for at least 8 hours and then have a low-fat breakfast about 2.5 hours before taking the medicine. The study plans to enroll about 12 children to ensure at least 10 complete the trial. Blood samples will be collected at multiple time points up to 12 hours after dosing to measure drug levels. During the study, participants will undergo blood sampling before and at 5, 15, and 30 minutes, then at 1, 1.25, 1.5, 2, 4, 6, 9, and 12 hours after taking the dose. Researchers will measure various pharmacokinetic outcomes such as drug concentration over time, peak levels, time to peak, elimination rate, and clearance. Participants and their guardians must comply with study visits, tests, and procedures. The total study duration is short, focusing on immediate drug monitoring after a single dose.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 11Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Children aged 6 to 11 years
Have acute painful condition requiring OTC analgesic in past 4 weeks (not within 48 hours before dosing), or recent dental/orthodontic procedure within 24 hours before dosing, or post-vaccination pain or low-grade fever
In normal health aside from medical condition requiring OTC analgesic or post-immunization symptoms
Able and willing to comply with study visits, treatment plan, lab tests, and procedures
Able to provide signed informed consent from parent/guardian and assent from child (verbal or written)
Within 5th to 95th percentile for height and weight by sex according to CDC growth charts
Total body weight between 48 and 95 pounds (21.8 to 43.1 kg)

You will not qualify if you...

History or evidence of significant blood, kidney, hormone, lung, stomach, heart, liver, psychiatric, neurological, or allergic diseases (except untreated seasonal allergies)
Conditions placing child at risk as judged by Investigator
History of angioedema or bronchospastic reaction to aspirin or NSAIDs
Known or suspected allergies or intolerance to ibuprofen, acetaminophen, aspirin, naproxen, or topical anesthetics
Use of antibiotics within 14 days before dosing
Use of ibuprofen, other NSAIDs, or acetaminophen within 48 hours before dosing
Use of prescription or nonprescription drugs or dietary/herbal supplements within 2 weeks before dosing
Participation in other investigational drug studies within 90 days
Participation in other studies involving investigational products within 30 days before consent or during study
Fever greater than 38.3°C or too ill to participate at screening or dosing
Blood pressure at or above 90th percentile for age and height after rest
Abnormal lab results judged clinically significant
Positive urine drug screen
Study staff or family members involved in the study
Blood withdrawal exceeding limits within 8 weeks before study
History of sensitivity to heparin or heparin-induced thrombocytopenia
Poor venous access
Unwilling or unable to comply with protocol
Recent intake of grapefruit or related citrus fruits within 2 weeks before dosing
Pregnant females of childbearing potential unwilling or unable to use contraception
History of substance abuse

Research Team

Haleon Response Center

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Study of Ibuprofen 62.5 mg and Acetaminophen 125 mg Oral Suspension in Children Ages 6 to 11 Years to Understand How the Medicines Work in the Body

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria