A Bioequivalence Study of Advil Dual Action Liquid Filled Capsules (125 mg/250 mg) Versus Advil Dual Action Caplets (125 mg/250 mg) and Bioavailability Assessment of Advil Dual Action Liquid Filled Capsules (125 mg/250 mg) and Advil Liqui-Gels (200 mg) in Healthy Adult Subjects

Last updated: April 22, 2025
Sponsor: HALEON
Overall Status: Completed

Phase

1

Condition

Pain

Treatment

ADA Caplets (Reference Product)

Advil Liqui-gels (Reference Product)

ADA Liquid Filled Capsules (Test Product)

Clinical Study ID

NCT06802185
300219
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary purpose of this study is to demonstrate the bioequivalence of new formulation Advil Dual Action (ADA) liquid filled capsules (Test) compared to the currently marketed ADA Caplet (Reference) under fasted conditions and to assess the relative bioavailability of ADA liquid filled capsules (Test) under fed conditions compared to ADA liquid filled capsules (Reference) under fasted conditions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant provision of a signed and dated informed consent document indicatingthat the participant has been informed of all pertinent aspects of the study beforeany assessment is performed.

  • Participant is male or female who, at the time of screening, is between the ages of 18 and 55 years, inclusive. An effort will be made to include similar proportions ofmales and females in the study.

  • Participant who is willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures.

  • A participant in good general and mental health with, in the opinion of theinvestigator or medically qualified designee, no clinically significant or relevantabnormalities in medical history or upon the physical examination, blood pressure (BP) and pulse rate measurement, 12-lead electrocardiogram (ECG) or clinicallaboratory tests, or condition, that would impact the participant's safety,wellbeing or the outcome of the study, if they were to participate in the study, oraffect the participant's ability to understand and follow study procedures andrequirements.

  • Body Mass Index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m^2); and atotal body weight more than or equal to (>=) 50.0 kilograms (kg) for males and >= 45.0 kg for females at screening.

  • Female participant of childbearing potential and at risk for pregnancy must agree touse a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment.

Exclusion

Exclusion Criteria:

  • A participant who is an employee of the investigational site, either directlyinvolved in the conduct of the study or a member of their immediate family; or anemployee of the investigational site otherwise supervised by the investigator; or, aHaleon employee directly involved in the conduct of the study or a member of theirimmediate family.

  • A participant who has participated in other studies (including non-medicinalstudies) involving investigational product(s) within 30 days prior to study entryand/or intends to participate in any other study during participation in this study.

  • A participant with, in the opinion of the investigator or medically qualifieddesignee, an acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with study participation orinvestigational product administration or may interfere with the interpretation ofstudy results and, in the judgment of the investigator or medically qualifieddesignee, would make the participant inappropriate for entry into this study.

  • Pregnant female participant as confirmed by a positive pregnancy test or intendingto become pregnant over the duration of the study.

  • Breastfeeding female participant.

  • Known or suspected intolerance or hypersensitivity to the study materials (orclosely related compounds) or any of their stated ingredients.

  • Any history of asthma, urticaria, or other significant allergic diathesis orallergic reaction to any other pain reliever/fever reducer. Participant withuncomplicated seasonal allergic rhinitis can be accepted if expected allergy seasonis clearly outside enrollment/treatment period.

  • Diagnosis of long QT syndrome or QT corrected for heart rate by Fridericia's cuberoot formula (QTcF) more than (>) 450 milliseconds (msec) for males and >470 msecfor females at screening.

  • Vital sign abnormalities (systolic BP lower than 90 or over 140 millimeters ofmercury (mmHg), diastolic BP lower than 50 or over 90 mmHg, or pulse rate less than 50 or over 100 beats per minute) unless determined by the Investigator or medicallyqualified designee to be not clinically significant. Vital signs may be repeated atthe discretion of the Investigator or medically qualified designee.

  • Unwilling or unable to comply with the Lifestyle Considerations described in thisprotocol.

  • Use of any medication (including over the counter medications and herbal remedies)within 2 weeks or within less than 10 times the elimination half-life of therespective drug (whichever is longer) before first scheduled study drugadministration, or is anticipated to require any concomitant medication during thatperiod or at any time throughout the study. Allowed treatments are:

  1. systemic contraceptives as long as female participant is on stable treatmentfor at least 3 months before first scheduled study drug administration andcontinues treatment throughout the study.
  • Evidence or history of clinically significant laboratory abnormality, hematological,renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, orallergic disease in the opinion of the Investigator, or medically qualified designeethat may increase the risk associated with study participation.

  • Any history of long-term treatment with carbamazepine, phenobarbitone, phenytoin,primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

  • Clinically relevant chronic or acute infectious illnesses or febrile infectionswithin 2 weeks prior to start of the study.

  • Any surgical or medical condition which may significantly alter the absorption,distribution, metabolism or excretion of any drug substance including, but notlimited to any of the following:

  1. History of major gastrointestinal tract surgery such as gastrectomy,gastroenterostomy, bowel resection, gastric bypass, gastric stapling or gastricbanding (note: this is not applicable for minor abdominal surgery withoutsignificant tissue resection, example, appendectomy and herniorrhaphy);

  2. History of inflammatory bowel disease or gastrointestinal bleeding includingpeptic ulcers;

  3. History or current evidence of renal disease or impaired renal function atscreening as demonstrated by an estimated glomerular filtration rate (eGFR)less than (<) 80 milliliters per minute per 1.73 meter^2 (ml/min/1.73 m^2)during screening (using the Chronic Kidney Disease Epidemiology Collaborationformula)

  4. History or current evidence of ongoing hepatic disease or impaired hepaticfunction at screening.

  5. A participant will be excluded if more than one of the following lab valuedeviations are found: 1) aspartate transaminase (AST) (>= 1.2 upper limit ofnormal [ULN]), alanine transaminase (ALT) (>=1.2 ULN), 2) gamma-glutamyltranspeptidase (GGT) (>=1.2 ULN), alkaline phosphatase (ALP) (>=1.2 ULN), 3)total bilirubin (>2.00 milligrams per deciliter [mg/dL]) or creatine kinase (>=3 ULN). A single deviation from the above values is acceptable and will notexclude the participant, unless specifically advised by the investigator, ormedically qualified designee;

  6. Evidence of urinary obstruction (example, due to benign prostate hyperplasia)or difficulty in voiding at screening;

  7. History or clinical evidence (on physical examination) at screening ofpancreatic injury or pancreatitis.

  • Any vaccination, including Coronavirus disease (COVID)-19 vaccine, within 14 daysprior to the first dose.

  • History of drug abuse within 1 year prior to screening or recreational use of softdrugs (such as marijuana) within 1 month or hard drugs (such as cocaine,phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetaminederivatives) within 3 months prior to dosing.

  • History of alcohol abuse within 1 year prior to screening or regular use of alcoholwithin 6 months prior to screening that exceeds 10 units for women or 15 units formen of alcohol per week (1 unit = 340 milliliters (mL) of beer 5 percent (%), 140 mLof wine 12%, or 45 mL of distilled alcohol 40%).

  • Positive urine drug screen or urine alcohol test at screening or Day -1.

  • Positive cotinine test at screening or Day -1

  • Participant reported regular consumption of beverages or food containing xanthinederivatives or xanthine-related compounds (example, coffee, tea, caffeine-containingsodas and chocolate), equivalent to >= 500 milligrams (mg) xanthine per day.

  • Current smoker, defined as the use of tobacco or nicotine products during the 3months prior to screening until admission to the unit.

  • Participant reports consumption of any drug metabolizing enzyme (example, CytochromeP450 3A4 [CYP3A4] or other cytochrome P450 enzymes) inducing or inhibiting aliments,beverages or food supplements (example, broccoli, Brussels sprouts, grapefruit,grapefruit juice, star fruit, St. John's Wort etcetera [etc.]) within 2 weeks priorto admission to the unit.

  • Positive results in any of the serology tests for human immunodeficiency virus (HIV)antigen (Ag) and antibody (Ab), Hepatitis C virus antibody (HCV-Ab), hepatitis Bsurface antigen (HBsAg) and hepatitis B core antibody (HBcAb) (immunoglobulin [Ig]G

  • IgM).
  • Performance of strenuous physical exercise (body building, high performance sports)from 2 weeks prior to admission and does not agree to refrain throughout the entirestudy.

  • Allergy to skin disinfecting agents, tape, or latex rubber, whenever appropriatesubstitutions cannot be applied or in the Investigator's or medically qualifieddesignee's opinion may pose a risk to the participant.

  • Any condition not identified in the protocol that in the opinion of the investigatoror medically qualified designee would confound the evaluation and interpretation ofthe study data or may put the participant at risk.

  • Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL ormore of whole blood within 8 weeks prior to dosing.

  • Hemoglobin value <12.0 grams per deciliter [g/dL] for males and <11.5 g/dL forfemales, may repeat at discretion of the Investigator or medically qualifieddesignee at screening or day -1.

  • Participant who has previously been enrolled in this study.

  • Participant has unsuitable veins for multiple venipunctures/cannulations as assessedby the investigator or delegate at screening.

Study Design

Total Participants: 54
Treatment Group(s): 3
Primary Treatment: ADA Caplets (Reference Product)
Phase: 1
Study Start date:
January 31, 2025
Estimated Completion Date:
April 12, 2025

Study Description

This is a single center, single oral dose, open-label, randomized, four-treatment, four period, four sequence, crossover, bioequivalence study of ADA liquid filled capsules (125 milligrams [mg] ibuprofen/250 mg acetaminophen) (Treatment A) versus (vs.) ADA Caplets (125 mg ibuprofen/250 mg acetaminophen) (Treatment B) in healthy adult participants under fasted conditions. The study also includes a bioavailability assessment of ADA liquid filled capsules (125 mg ibuprofen/250 mg acetaminophen) under fed conditions (Treatment C) and Advil Liqui-Gels (200 mg ibuprofen) under fasted conditions (Treatment D). A sufficient number of male and female participants will be screened to randomize approximately 54 to ensure at least 48 evaluable participants complete the entire study. Participants will be randomly assigned to 1 of the 4 treatment sequences and receive a single oral dose of the investigational products per the randomization in each period following a crossover design. There will be a wash-out period of 3 days between investigational product administrations. Blood will be sampled regularly at scheduled times for 24 hours following treatment in each period to assess the pharmacokinetic parameters.

Connect with a study center

  • Spaulding Clinical

    West Bend, Wisconsin 53095
    United States

    Site Not Available

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