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ADA Liquid Filled

Phase 1

Pain | Small molecule | Pain |Haleon plc|Last Updated: Apr 23, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06802185A 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 SubjectsPHASE1 COMPLETED 54 — — Jan 31, 2025Apr 12, 2025Apr 23, 20251 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Post-dose Concentration (Cmax) for Ibuprofen Under Fasted Conditions (ADA Liquid Filled Capsules [Treatment A] vs. ADA Caplet [Treatment B])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 3 days)

Cmax is defined as the maximum observed post-dose concentration for ibuprofen 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]) for Ibuprofen Under Fasted Conditions (ADA Liquid Filled Capsules [Treatment A] vs. ADA Caplet [Treatment B])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 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 Acetaminophen Under Fasted Conditions (ADA Liquid Filled Capsules [Treatment A] vs. ADA Caplet [Treatment B])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 3 days)

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

AUC(0-t) for Acetaminophen Under Fasted Conditions (ADA Liquid Filled Capsules [Treatment A] vs. ADA Caplet [Treatment B])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 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 Ibuprofen (ADA Liquid Filled Capsules Under Fed Conditions [Treatment C] vs. ADA Liquid Filled Capsules Under Fasted Conditions [Treatment A])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 3 days)

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

AUC(0-t) for Ibuprofen (ADA Liquid Filled Capsules Under Fed Conditions [Treatment C] vs. ADA Liquid Filled Capsules Under Fasted Conditions [Treatment A])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 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 Ibuprofen (ADA Liquid Filled Capsules Under Fed Conditions [Treatment C] vs. ADA Liquid Filled Capsules Under Fasted Conditions [Treatment A])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 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).

Cmax for Acetaminophen (ADA Liquid Filled Capsules Under Fed Conditions [Treatment C] vs. ADA Liquid Filled Capsules Under Fasted Conditions [Treatment A])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 3 days)

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

AUC(0-t) for Acetaminophen (ADA Liquid Filled Capsules Under Fed Conditions [Treatment C] vs. ADA Liquid Filled Capsules Under Fasted Conditions [Treatment A])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 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).

AUC(0-inf) for Acetaminophen (ADA Liquid Filled Capsules Under Fed Conditions [Treatment C] vs. ADA Liquid Filled Capsules Under Fasted Conditions [Treatment A])
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 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
Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) for Ibuprofen (Treatment A, Treatment C, Treatment B and Treatment D)
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 3 days)
AUC(0-inf) for Ibuprofen (Treatment A, Treatment C, Treatment B and Treatment D)
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 3 days)
Terminal Elimination Rate Constant (λz) for Ibuprofen (Treatment A, Treatment C, Treatment B and Treatment D)
Pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 0.75, 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, 8,10,12,16,20, and 24 hours post dose on Day 1 in each treatment period (each period is of 3 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Sequence 1: Treatment A + Treatment B + Treatment C + Treatment DEXPERIMENTALParticipants will receive a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 1 (Treatment A), followed by a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 2 (Treatment B), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 3 (Treatment C) and further followed by a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 4 (Treatment D). There will be a washout period of at least 3 days between each treatment.
Sequence 2: Treatment B + Treatment D + Treatment A + Treatment CEXPERIMENTALParticipants will receive a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 1 (Treatment B), followed by a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 2 (Treatment D), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 3 (Treatment A) and further followed by a single oral dose of ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 4 (Treatment C). There will be a washout period of at least 3 days between each treatment.
Sequence 3: Treatment C + Treatment A + Treatment D + Treatment BEXPERIMENTALParticipants will receive a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 1 (Treatment C), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 2 (Treatment A), followed by a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 3 (Treatment D) and further followed by a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 4 (Treatment B). There will be a washout period of at least 3 days between each treatment.
Sequence 4: Treatment D + Treatment C + Treatment B + Treatment AEXPERIMENTALParticipants will receive a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 1 (Treatment D), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 2 (Treatment C), followed by a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 3 (Treatment B), and further followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 4 (Treatment A). There will be a washout period of at least 3 days between each treatment.
Interventions
NameTypeDescription
ADA Liquid Filled Capsules (Test Product)DRUGADA liquid filled capsules containing 125 mg ibuprofen and 250 mg acetaminophen.
ADA Caplets (Reference Product)DRUGADA Caplets containing 125 mg ibuprofen and 250 mg acetaminophen.
Advil Liqui-gels (Reference Product)DRUGAdvil Liqui-gels containing 200 mg ibuprofen.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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 ...

Countries:United States
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