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

Completed · Phase 1

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT06802185

Run by

HALEON

People needed

54

Starts

2025-01-31

Expected to finish

2025-04-12

Last updated by the study team

2025-04-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any 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 of males 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 the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon the physical examination, blood pressure (BP) and pulse rate measurement, 12-lead electrocardiogram (ECG) or clinical laboratory 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, or affect the participant's ability to understand and follow study procedures and requirements.
• Body Mass Index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m\^2); and a total 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 to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment.

You may not qualify if…

• A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
• A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or intends to participate in any other study during participation in this study.
• A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• Pregnant female participant as confirmed by a positive pregnancy test or intending to become pregnant over the duration of the study.
• Breastfeeding female participant.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Any history of asthma, urticaria, or other significant allergic diathesis or allergic reaction to any other pain reliever/fever reducer. Participant with uncomplicated seasonal allergic rhinitis can be accepted if expected allergy season is clearly outside enrollment/treatment period.
• Diagnosis of long QT syndrome or QT corrected for heart rate by Fridericia's cube root formula (QTcF) more than (>) 450 milliseconds (msec) for males and >470 msec for females at screening.
• Vital sign abnormalities (systolic BP lower than 90 or over 140 millimeters of mercury (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 medically qualified designee to be not clinically significant. Vital signs may be repeated at the discretion of the Investigator or medically qualified designee.
• Unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
• 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 the respective drug (whichever is longer) before first scheduled study drug administration, or is anticipated to require any concomitant medication during that period or at any time throughout the study. Allowed treatments are:
• systemic contraceptives as long as female participant is on stable treatment for at least 3 months before first scheduled study drug administration and continues treatment throughout the study.
• Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease in the opinion of the Investigator, or medically qualified designee that 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 infections within 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 not limited to any of the following:
• History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling or gastric banding (note: this is not applicable for minor abdominal surgery without significant tissue resection, example, appendectomy and herniorrhaphy);
• History of inflammatory bowel disease or gastrointestinal bleeding including peptic ulcers;
• History or current evidence of renal disease or impaired renal function at screening 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 Collaboration formula)
• History or current evidence of ongoing hepatic disease or impaired hepatic function at screening.
• A participant will be excluded if more than one of the following lab value deviations are found: 1) aspartate transaminase (AST) (>= 1.2 upper limit of normal [ULN]), alanine transaminase (ALT) (>=1.2 ULN), 2) gamma-glutamyl transpeptidase (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 not exclude the participant, unless specifically advised by the investigator, or medically qualified designee;
• Evidence of urinary obstruction (example, due to benign prostate hyperplasia) or difficulty in voiding at screening;
• History or clinical evidence (on physical examination) at screening of pancreatic injury or pancreatitis.
• Any vaccination, including Coronavirus disease (COVID)-19 vaccine, within 14 days prior to the first dose.
• History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to dosing.

Where it is running

• Spaulding Clinical — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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