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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: Test Product

Detailed Description

This will be a single-center, open-label PK study to assess the pharmacokinetic profile of IBU and APAP from a single oral dose of FDC IBU 62.5 mg/APAP 125 mg per 5 mL liquid suspension in children. Following an overnight fast of at least 8 hours, participants will receive a low-fat breakfast approximately 2.5 hours prior to dosing. The study will enroll approximately 12 children between the ages of 6 and 11 years, inclusive, with the goal of ensuring that at least 10 evaluable participants complete the study.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Haleon Response Center; Phone Number: +441932959500; Email: ww.clinical-trial-register@haleon.com

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • CenExel Salt Lake
      • Contact: Todd Bertouch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 within the previous 4 weeks (but not within the 48 hours prior to Day 1, Hour 0 investigational product dosing).
  2. 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.
  3. Participant with post-vaccination pain (post-injection site redness/soreness, joint pain) and/or fever at time of investigational product dosing.
  4. 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.
• Participants except for medical condition(s) indicating the use of an OTC analgesic or post-immunization pain and/or fever, participants are in normal health as judged by the Investigator upon physical examination of the participant.
• Participants/parent(s)/legal guardian who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in this protocol. A personally signed and dated informed consent document indicates that the child's parent(s)/legal guardian has been informed of all pertinent aspects of the study.
• Participants with evidence of a personally signed (printed name is acceptable) and dated assent document or verbal assent, indicating the participant is willing to participate in the study. If assent is evaluated not to be obtainable, age and maturity appropriate information should be given verbally to the participants, and the Investigator should document the discussion.
• Participants who are within the 5th and 95th percentiles in physical growth characteristics (i.e., height and weight) by sex as described by the Center for Disease Control and Prevention (CDC) standard growth charts, and body mass index (BMI) based on age and sex.
• Participants must have a total body weight between 48-95 lbs (21.8-43.1 kilogram (kg)).

Exclusion Criteria:

• Participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Participants with any condition or history felt by the Investigator to place the child at risk.
• Participants with history of angioedema and bronchospastic reactivity to aspirin or other non-steroidal anti-inflammatory drug (NSAID).
• Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients: Ibuprofen, or any other NSAID such as aspirin or naproxen, acetaminophen (paracetamol), or topical anesthetics (e.g., EMLA® cream).
• Participants with use of antibiotic therapy within 14 days prior to Day 1.

• Participants using the following:

  1. Ibuprofen, or any other NSAID such as aspirin or naproxen, or acetaminophen (paracetamol) within 48 hours prior to dosing with investigational product.
  2. Other prescription or nonprescription drugs within 2 weeks or 10 half-lives (whichever is longer) prior to dosing with investigational product.
  3. Dietary and herbal supplements within 2 weeks prior to the first dose of investigational product and continuing through the last PK sample on Day 1.
• Participants on treatment with an investigational drug within 90 days (or as determined by the local requirement) or 10 half-lives preceding the first dose of investigational product (whichever is longer).
• Participants who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to signing the Informed Consent Form (ICF)/assent and/or during study participation.
• Fever of greater than 38.3°C or if the participant is too ill to participate in the study, at screening and Day 1/Day 1 of the study.
• Screening supine systolic or diastolic blood pressure (BP) at or above the 90th percentile based on age and height percentiles (by sex) following at least 5 minutes of supine rest.
• Participants with any laboratory result outside of the normal age-appropriate range that is judged by the Investigator to be clinically significant.
• Participants with a positive urine drug screen.
• Investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or Haleon employees, including their family members, directly involved in the conduct of the study.
• Blood withdrawal as part of research or routine medical care, within 8 weeks of admission to the study site that would exceed 1.36 mL/lbs per 8 weeks period, inclusive of medical care and planned sample collection for this study.
• Participants with history of sensitivity to heparin or heparin-induced thrombocytopenia.
• Participants with poor venous access.
• Participants or participant parent(s)/guardians unwilling or unable to comply with the requirements of the protocol.
• Participants who ate or drank grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos) from 2 weeks prior to dosing until collection of the final PK blood sample will be excluded as it could interfere with acetaminophen disposition.
• Pregnant female participants of childbearing potential and at risk for pregnancy who are unwilling or unable to agree to an acceptable method of contraception for at least 5 weeks prior to the start of the trial, during the trial and for at least 30 days after the last dose of the investigational product.
• Participants with history of substance abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Test Product; Liquid suspension FDC IBU 62.5 mg / APAP 125 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	AUC(0-t) will be defined as the area under the plasma concentration Vs. time curve calculated from time 0 to the last measurable sampling time point, t and will be computed using the linear trapezoidal rule. Blood samples will be collected at indicated time points for the analysis of AUC(0-t).	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	AUC0-inf will be defined as the area under the plasma concentration Vs. time curve calculated from time 0 to infinity. AUC0-inf equal to (=) AUC0-t addition (+) Clast divided by (/) λz, where Clast will be the concentration at the last measurable sampling time point and λz will be the terminal elimination rate constant. Blood samples will be collected at indicated timepoints for the analysis of AUC0-inf.	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	Cmax will be defined as the maximum observed plasma concentration for Test Product. Blood samples will be collected at indicated timepoints for the analysis of Cmax.	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	Tmax will be defined as the time to reach the maximum observed plasma concentration for Test Product. Blood samples will be collected at indicated timepoints for the analysis of Tmax.	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	λz will be defined as the apparent terminal elimination rate constant determined by log-linear regression. The regression will generally involve at least 3 consecutive measurable concentrations that decrease over time, excluding Cmax. Blood samples will be collected at indicated timepoints for the analysis of Cmax.	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
Terminal Half-Life (t1/2) for Ibuprofen and Acetaminophen	t1/2 will be defined as the elimination half-life computed as t1/2 = natural logarithm (ln)(2)/λz. Blood sample will be collected at indicated timepoints for analysis of t1/2.	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 Volume of Distribution (Vz/F) for Ibuprofen and Acetaminophen	Vz/F will be defined as apparent volume of distribution and will be calculated by the dose administered/ (λz multiply by (×) AUC0-inf). Blood sample will be collected at indicated timepoints for the analysis of Vz/F.	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 Total Clearance (Cl/F) for Ibuprofen and Acetaminophen	Cl/F will be defined as apparent total clearance and will be calculated by the dose administered/AUC0-inf. Blood sample will be collected at indicated timepoints for the analysis of Cl/F.	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 Volume of Distribution, Adjusted for Body Size (Vz/F/lbs) for Ibuprofen and Acetaminophen	Vz/F/lbs will be defined as apparent volume of distribution, adjusted for body size. Blood sample will be collected at indicated timepoints for the analysis of Vz/F/lbs.	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 Total Clearance, Adjusted for Body Size (Cl/F/lbs) for Ibuprofen and Acetaminophen	Cl/F/lbs will be defined as apparent total clearance, adjusted for body size. Blood sample will be collected at indicated timepoints for the analysis of Cl/F/lbs.	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

Collaborators and Investigators

• Sponsor: HALEON

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 400047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No