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Advil

Phase 1

Bioequivalence | Small molecule | Other |Haleon plc|Last Updated: Mar 13, 2026

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Advil · 1 trial · 2 indications

Phase 1 1
NCT07345130A 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 ConditionsBioequivalence
COMPLETED50 Analytics
PHASE1COMPLETED
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
Bioequivalence
NCT0734513050
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Study Endpoints

Primary Endpoints

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

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)
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) 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).

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

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

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
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-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).

Secondary Endpoints

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)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence 1: Treatment A/ Treatment B/ Treatment CEXPERIMENTALParticipants 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.
Sequence 2: Treatment B/ Treatment C/ Treatment AEXPERIMENTALParticipants 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.
Sequence 3: Treatment C/ Treatment A/ Treatment BEXPERIMENTALParticipants 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.
Sequence 4: Treatment A/ Treatment C/ Treatment BEXPERIMENTALParticipants 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.
Sequence 5: Treatment B/ Treatment A/ Treatment CEXPERIMENTALParticipants 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.
Sequence 6: Treatment C/ Treatment B/ Treatment AEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
Advil Tablet (Mini) (Test Product)DRUG200 mg Ibuprofen
Advil Tablet (Reference Product)DRUG200 mg Ibuprofen
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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 ...

Countries:United States
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Frequently asked questions about Advil

What is Advil used for?

Advil is a small molecule drug being studied for bioequivalence and bioavailability. It contains ibuprofen 200 mg and is being evaluated in healthy adult subjects under fasted and fed conditions. The drug is currently in Phase 1 clinical development.

Who makes Advil?

Advil is developed by Haleon plc, a company traded on the stock exchange under the ticker HLN. The company is conducting clinical trials to assess the bioequivalence and bioavailability of Advil tablet formulations.

What phase is Advil in?

Advil is in Phase 1 clinical development. The drug is investigational and not yet approved for marketing. A Phase 1 bioequivalence study has been completed to evaluate the drug's performance in healthy volunteers.

What clinical trials is Advil in?

Advil has one completed clinical trial, NCT07345130, which studied bioequivalence of Advil Tablet (Mini) (Ibuprofen 200 mg) versus Advil Tablet (Ibuprofen 200 mg) in healthy adult subjects under fasted conditions, plus bioavailability assessment under fed conditions. The trial enrolled 50 participants in the United States.

Is Advil the same as ibuprofen?

Advil contains ibuprofen 200 mg as its active ingredient. The drug is being studied to compare the bioequivalence of a mini tablet formulation versus a standard tablet formulation, both containing the same dose of ibuprofen.