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NCT07632274

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
PHASE1Ages 6–11Interventional
HALEON
~12 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Test Product

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
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
Measured over 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
+9 more outcomes measured

Conditions

Pain

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FeverPain

Where it's being run

1 sites across 1 states
Utah1

Who to contact

Haleon Response Center
[email protected]
+441932959500
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Eligibility criteria

Inclusion

Participants meeting at least one of the following criteria:
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

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:
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.

What this trial measures

  • 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 AcetaminophenPre-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

    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).

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

    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.

  • Peak or Maximum Observed Plasma Concentration (Cmax) for Ibuprofen and AcetaminophenPre-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

    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.

  • Time to Reach Maximum Plasma Concentration (Tmax) for Ibuprofen and AcetaminophenPre-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

    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.

  • Apparent Terminal Elimination Rate Constant (λz) for Ibuprofen and AcetaminophenPre-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

    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.

  • Terminal Half-Life (t1/2) for Ibuprofen and AcetaminophenPre-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

    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.

  • Apparent Volume of Distribution (Vz/F) for Ibuprofen and AcetaminophenPre-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

    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.

  • Apparent Total Clearance (Cl/F) for Ibuprofen and AcetaminophenPre-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

    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.

  • Apparent Volume of Distribution, Adjusted for Body Size (Vz/F/lbs) for Ibuprofen and AcetaminophenPre-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

    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.

  • Apparent Total Clearance, Adjusted for Body Size (Cl/F/lbs) for Ibuprofen and AcetaminophenPre-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

    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.