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Advil PM Liqui-Gels Minis

Phase 1

Pain | Small molecule | Pain |Haleon plc|Last Updated: Aug 23, 2024

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05674721A Bioequivalence Study of Advil PM Liqui-Gels Minis (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) Compared to the Current Marketed Advil PM Liqui-Gels (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) in Healthy Adult Subjects Under Fasted ConditionsPHASE1 COMPLETED 77 — — Jan 5, 2023Mar 21, 2023Aug 23, 20241 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) for Ibuprofen
1 hour prior to dosing (pre-dose) and at 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, 5.25, 5.5, 6, 8,10,12 and 16 hours post-dose on Day 1 (First Intervention) and Day 11 (Second Intervention)

Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen obtained without interpolation. Blood samples were collected at indicated timepoints and pharmacokinetic (PK) analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.

Cmax for Diphenhydramine
1 hour prior to dosing (pre-dose) and at 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, 5.25, 5.5,6,8,10,12,16,24,36, and 48 hours post-dose on Day 1 (First Intervention) and Day 11 (Second Intervention)

Cmax was defined as maximum observed post-dose plasma concentration for diphenhydramine obtained without interpolation. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.

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
1 hour prior to dosing (pre-dose) and at 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, 5.25, 5.5, 6, 8,10,12 and 16 hours post-dose on Day 1 (First Intervention) and Day 11 (Second Intervention)

AUC (0-t) was defined as the area under the plasma concentration versus time curve calculated from time zero to the last measurable sampling time point, (t) using linear up log down trapezoidal method. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.

AUC (0-t) for Diphenhydramine
1 hour prior to dosing (pre-dose) and at 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, 5.25, 5.5,6,8,10,12,16,24,36, and 48 hours post-dose on Day 1 (First Intervention) and Day 11 (Second Intervention)

AUC (0-t) was defined as the area under the plasma concentration versus time curve calculated from time zero to the last measurable sampling time point, (t) using linear up log down trapezoidal method. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.

Area Under the Plasma Concentration Versus Time Curve Calculated From Time 0 to Infinity (AUC [0-inf]) for Ibuprofen
1 hour prior to dosing (pre-dose) and at 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, 5.25, 5.5, 6, 8,10,12 and 16 hours post-dose on Day 1 (First Intervention) and Day 11 (Second Intervention)

AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC0-inf = AUC0-t + C(last)/λz where C(last) was the concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.

AUC (0-inf) for Diphenhydramine
1 hour prior to dosing (pre-dose) and at 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, 5.25, 5.5,6,8,10,12,16,24,36, and 48 hours post-dose on Day 1 (First Intervention) and Day 11 (Second Intervention)

AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity computed as AUC0-inf = AUC0-t + C(last)/λz where C(last) was the concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.

Secondary Endpoints
Terminal Elimination Rate Constant (λz) for Ibuprofen
1 hour prior to dosing (pre-dose) and at 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, 5.25, 5.5, 6, 8,10,12 and 16 hours post-dose on Day 1 (First Intervention) and Day 11 (Second Intervention)
λz for Diphenhydramine
1 hour prior to dosing (pre-dose) and at 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, 5.25, 5.5,6,8,10,12,16,24,36, and 48 hours post-dose on Day 1 (First Intervention) and Day 11 (Second Intervention)
Time of the Maximum Observed Post-dose Concentration (Tmax) for Ibuprofen
1 hour prior to dosing (pre-dose) and at 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, 5.25, 5.5, 6, 8,10,12 and 16 hours post-dose on Day 1 (First Intervention) and Day 11 (Second Intervention)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Advil PM Liqui-Gels MinisEXPERIMENTALParticipants will be randomly assigned as per cross-over design to receive a single dose of 2 Advil PM Liqui-Gels Minis capsules orally on day 1 of period 1 and will receive single dose of 2 Advil PM Liqui-Gels capsules orally on day 1 of period 2 with at least 7 days washout period. Participants will be instructed to consume the entire amount of ambient temperature water (approximately 240 milliliters \[mL\]) along their investigational product.
Advil PM Liqui-GelsACTIVE_COMPARATORParticipants will be randomly assigned as per cross-over design to receive a single dose of 2 Advil PM Liqui-Gels capsules orally on day 1 of period 1 and will receive single dose of 2 Advil PM Liqui-Gels Minis capsules orally on day 1 of period 2 with at least 7 days washout period. Participants will be instructed to consume the entire amount of ambient temperature water (approximately 240 mL) along their investigational product.
Interventions
NameTypeDescription
Advil PM Liqui-Gels MinisDRUGIbuprofen/diphenhydramine hydrochloride 200 mg/25 mg, Oral capsule which is a size reduction of the currently marketed reference product.
Advil PM Liqui-GelsDRUGIbuprofen/diphenhydramine hydrochloride 200 mg/25 mg, Oral capsule.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Evidence of a personally 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 who is willing and able to comply with scheduled visits, treatment plan...

Countries:United States
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