Not Yet RecruitingPhase 1

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

United States12 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range

6 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 within the previous 4 weeks (but not within the 48 hours prior to Day 1, Hour 0 investigational product dosing).
. Participant has undergone a non-surgical orthodontic or dental procedure (e.g., placement of an orthodontic appliance or adjustment of braces) within 24 hours prior to dosing.
. Participant with post-vaccination pain (post-injection site redness/soreness, joint pain) and/or fever at time of investigational product dosing.
. Participants who have a fever at time of investigational product dosing can be enrolled as long as the fever is low-grade (oral temperature less than (\<) 37.7 degree Celsius (°C) /100.9 degrees Fahrenheit (ºF)) and, regardless of temperature, the fever has not lasted for more than (\>) 48 hours as determined by the Investigator.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Area Under the Plasma Concentration Vs. Time Curve Calculated from Time 0 To Infinity (AUC0-inf) for Ibuprofen and Acetaminophen

Timeframe: 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

Peak or Maximum Observed Plasma Concentration (Cmax) for Ibuprofen and Acetaminophen

Timeframe: 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

Time to Reach Maximum Plasma Concentration (Tmax) for Ibuprofen and Acetaminophen

Timeframe: 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

Apparent Terminal Elimination Rate Constant (λz) for Ibuprofen and Acetaminophen

Timeframe: 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

Trial details

NCT IDNCT07632274

SponsorHALEON

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Haleon Response Center

+441932959500 ww.clinical-trial-register@haleon.com

View on ClinicalTrials.gov More Pain trials

Who can participate

Age range

6 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 within the previous 4 weeks (but not within the 48 hours prior to Day 1, Hour 0 investigational product dosing).
. Participant has undergone a non-surgical orthodontic or dental procedure (e.g., placement of an orthodontic appliance or adjustment of braces) within 24 hours prior to dosing.
. Participant with post-vaccination pain (post-injection site redness/soreness, joint pain) and/or fever at time of investigational product dosing.
. Participants who have a fever at time of investigational product dosing can be enrolled as long as the fever is low-grade (oral temperature less than (\<) 37.7 degree Celsius (°C) /100.9 degrees Fahrenheit (ºF)) and, regardless of temperature, the fever has not lasted for more than (\>) 48 hours as determined by the Investigator.