PainPhase 1NCT07632274
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 1 study testing Test Product in people with Pain, run by HALEON at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Test Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2026to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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)).
Who cannot join
- 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:
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CenExel Salt Lake
Salt Lake City, Utah, 84107
Todd Bertouch, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Test Product
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ProductDrug
Liquid suspension FDC IBU 62.5 mg / APAP 125 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Test Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start19 Jun 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632274
- Sponsor's protocol ID
- 400047
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07632274
- Acronym / sponsor ID
- 400047
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Test ProductParticipants 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test ProductLiquid suspension FDC IBU 62.5 mg / APAP 125 mg | Drug | Test Product |
Primary outcome
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
Time frame: 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
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 Acetaminophen
Time frame: 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
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 Acetaminophen
Time frame: 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
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 Acetaminophen
Time frame: 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
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 Acetaminophen
Time frame: 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
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 Acetaminophen
Time frame: 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
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 Acetaminophen
Time frame: 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
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 Acetaminophen
Time frame: 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
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 Acetaminophen
Time frame: 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
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 Acetaminophen
Time frame: 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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test Product in people with Pain, run by HALEON at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haleon Response Center (+441932959500, ww.clinical-trial-register@haleon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.