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

NCT07632274 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 400047
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Test Product

EXPERIMENTAL

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

Interventions

Test Product DRUG

Liquid suspension FDC IBU 62.5 mg / APAP 125 mg

Test Product

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants meeting at least one of the following 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.
• 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)).

You may not qualify if:

• 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:
• Ibuprofen, or any other NSAID such as aspirin or naproxen, or acetaminophen (paracetamol) within 48 hours prior to dosing with investigational product.
• Other prescription or nonprescription drugs within 2 weeks or 10 half-lives (whichever is longer) prior to dosing with investigational product.
• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

CenExel Salt Lake

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Haleon Response Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)