Recent Updates
Recently added Catalysts

Advil

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 ConditionsPHASE1 COMPLETED 50 — — Dec 17, 2025Feb 3, 2026Mar 13, 20261 United States
Unlock Drug Trial Details
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)
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
MEDIUMMay 21, 2026NCT07345130TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT07345130TRIAL_REMOVED: changed