A Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen 200 mg) Versus Advil Tablet (Ibuprofen 200 mg) in Healthy Adult Subjects Under Fasted Conditions and Bioavailability Assessment of Advil Tablet (Mini) Under Fed Conditions

NCT07345130 | Completed Phase 1 FDA Drug

• 1 other identifier: 300286
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the bioequivalence of Advil Tablet (Mini) (Test Product) to Advil Tablet (Reference Product) under fasted conditions and to characterize the impact of food on the bioavailability of the Test Product under fed conditions.

Conditions

Bioequivalence; Bioavailability

Outcome Measures

Primary Outcomes (5)

• Maximum Observed Post-dose Concentration (Cmax) Under Fasted Conditions (Test Versus (vs) Reference Product)

  Cmax is defined as the maximum observed post-dose concentration obtained without interpolation. Blood samples will be collected at indicated timepoints for the analysis of Cmax.

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

• Area Under the Plasma Concentration Versus Time Curve Calculated from Time 0 to the Last Measurable Sampling Time Point, t (AUC[0-t]) Under Fasted Conditions (Test Vs Reference Product)

  AUC(0-t) is defined as the area under the plasma concentration versus time curve calculated from time 0 to the last measurable sampling time point, t, computed using the linear trapezoidal rule. Blood samples will be collected at indicated timepoints for the analysis of AUC(0-t).

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

• Cmax for Test Product Under Fed Conditions Compared to Fasted Conditions

  Cmax is defined as the maximum observed post-dose concentration obtained without interpolation. Blood samples will be collected at indicated timepoints for the analysis of Cmax.

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

• AUC(0-t) for Test Product Under Fed Conditions Compared to Fasted Conditions

  AUC(0-t) is defined as the area under the plasma concentration versus time curve calculated from time 0 to the last measurable sampling time point, t, computed using the linear trapezoidal rule. Blood samples will be collected at indicated timepoints for the analysis of AUC(0-t).

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

• Area Under the Plasma Concentration Versus Time Curve Calculated From Time 0 to Infinity (AUC[0-inf]) for Test Product Under Fed Conditions Compared to Fasted Conditions

  AUC(0-inf) is defined as the area under the plasma concentration versus time curve calculated from time 0 to infinity. AUC(0-inf) = AUC(0-t) + C(t)/λz where C(t) is the concentration at the last measurable sampling time point and λz is the terminal elimination rate constant. Blood samples will be collected at indicated timepoints for the analysis of AUC(0-inf).

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

Secondary Outcomes (9)

• AUC(0-inf) for Test and Reference Products

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

• Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) for Test and Reference Products

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

• Terminal Elimination Rate Constant (λz) for Test and Reference Products

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

• Time of the Maximum Observed Post-dose Concentration (tmax) for Test and Reference Products

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

• Elimination Half-life (t1/2) for Test and Reference Products

  Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)

Study Arms (6)

Sequence 1: Treatment A/ Treatment B/ Treatment C

EXPERIMENTAL

Participants will receive a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 1 (Treatment A), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 2 (Treatment B), followed by a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 3 (Treatment C). There will be a washout period of at least 3 days between each treatment.

Drug: Advil Tablet (Mini) (Test Product); Drug: Advil Tablet (Reference Product)

Sequence 2: Treatment B/ Treatment C/ Treatment A

EXPERIMENTAL

Participants will receive a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 1 (Treatment B), followed by a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 2 (Treatment C), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 3 (Treatment A). There will be a washout period of at least 3 days between each treatment.

Drug: Advil Tablet (Mini) (Test Product); Drug: Advil Tablet (Reference Product)

Sequence 3: Treatment C/ Treatment A/ Treatment B

EXPERIMENTAL

Participants will receive a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 1 (Treatment C), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 2 (Treatment A), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 3 (Treatment B). There will be a washout period of at least 3 days between each treatment.

Drug: Advil Tablet (Mini) (Test Product); Drug: Advil Tablet (Reference Product)

Sequence 4: Treatment A/ Treatment C/ Treatment B

EXPERIMENTAL

Participants will receive a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 1 (Treatment A), followed by a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 2 (Treatment C), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 3 (Treatment B). There will be a washout period of at least 3 days between each treatment.

Drug: Advil Tablet (Mini) (Test Product); Drug: Advil Tablet (Reference Product)

Sequence 5: Treatment B/ Treatment A/ Treatment C

EXPERIMENTAL

Participants will receive a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 1 (Treatment B), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 2 (Treatment A), followed by a single oral dose of Advil (Mini) under fed conditions on Day 1 of Period 3 (Treatment C). There will be a washout period of at least 3 days between each treatment.

Drug: Advil Tablet (Mini) (Test Product); Drug: Advil Tablet (Reference Product)

Sequence 6: Treatment C/ Treatment B/ Treatment A

EXPERIMENTAL

Participants will receive a single oral dose of Advil (Mini) under fed conditions on Day 1 of Period 1 (Treatment C), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 2 (Treatment B), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 3 (Treatment A). There will be a washout period of at least 3 days between each treatment.

Drug: Advil Tablet (Mini) (Test Product); Drug: Advil Tablet (Reference Product)

Interventions

Advil Tablet (Mini) (Test Product) DRUG

200 mg Ibuprofen

Sequence 1: Treatment A/ Treatment B/ Treatment C; Sequence 2: Treatment B/ Treatment C/ Treatment A; Sequence 3: Treatment C/ Treatment A/ Treatment B; Sequence 4: Treatment A/ Treatment C/ Treatment B; Sequence 5: Treatment B/ Treatment A/ Treatment C; Sequence 6: Treatment C/ Treatment B/ Treatment A

Advil Tablet (Reference Product) DRUG

200 mg Ibuprofen

Sequence 1: Treatment A/ Treatment B/ Treatment C; Sequence 2: Treatment B/ Treatment C/ Treatment A; Sequence 3: Treatment C/ Treatment A/ Treatment B; Sequence 4: Treatment A/ Treatment C/ Treatment B; Sequence 5: Treatment B/ Treatment A/ Treatment C; Sequence 6: Treatment C/ Treatment B/ Treatment A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant provision of a signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• A participant whose biological sex at birth is male or female.
• A participant who is 18 to 55 years of age inclusive, at the signing of the ICF.
• A participant who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, study restrictions 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 physical examination, vital sign measurements, 12-lead electrocardiogram (ECG) or clinical laboratory tests, or condition, that would impact the participant 's safety, well-being or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
• A participant with a body mass index (BMI) of between 18.5 and 30.0 kilogram per meter square (kg/m\^2); and a total body weight more than or equal to (\>=) 50.0 kg for males and \>=45.0 kg for females.
• A 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. A female participant who is not of childbearing potential must meet at least one of the following criteria:
• Has achieved postmenopausal status, defined as cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level \>=40 milli-international units per milliliter (mIU/mL).
• Has undergone a documented (including self-reported) hysterectomy and/or bilateral oophorectomy.

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 during study participation.
• 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.
• A female participant who is pregnant (as confirmed by a positive pregnancy test) or intending to become pregnant over the duration of the study.
• A female participant who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• A participant with any history of asthma, urticaria, or other significant allergic diathesis or allergic reaction to any other pain reliever/fever reducer (example, aspirin or other non-steroidal anti-inflammatory drugs \[NSAIDs\]). Childhood asthma may be acceptable at the discretion of the Investigator. A participant with uncomplicated seasonal allergic rhinitis can be accepted if expected allergy season is clearly outside enrollment/treatment period.
• A participant with a diagnosis of long QT syndrome or QTcF greater than (\>)450 millisecond (msec) for males and \>470 msec for females at screening.
• A participant with clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 millimeter of mercury (mmHg), diastolic blood pressure lower than 50 or over 90 mmHg, or pulse rate less than 50 or over 100 beats per minute \[bpm\]).
• A participant unwilling or unable to comply with Lifestyle Considerations described in this protocol.
• A participant who has used any medication (including over the counter \[OTC\] 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 and hormone replacement therapy, 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.
• occasional use of acetaminophen (up to 2 gram \[g\] daily).
• A participant with evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation, in the opinion of the Investigator or medically qualified designee.
• A participant with clinically relevant chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 15, 2026
• Study Start: December 17, 2025
• Primary Completion: February 3, 2026
• Study Completion: February 3, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

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)