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Paracetamol ODT

Phase 1

Fever | Small molecule | Pain |Haleon plc|Last Updated: May 6, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06855576Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting ConditionsPHASE1 COMPLETED 54 — — Mar 5, 2025Apr 17, 2025May 6, 20251 Germany
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Study Endpoints
Primary Endpoints
Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (Vs) Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period

Cmax is defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples will be collected at indicated timepoints for the analysis of Cmax. Pharmacokinetic (PK) parameters will be determined by non-compartmental analysis.

Area Under the Concentration Versus Time Curve from Dosing Time to the Last Measurement Time Point (AUC0-tlast) for Paracetamol ODT (Test) Vs Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period

AUC0-tlast is defined as area under the concentration Vs time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations). Blood samples will be collected at indicated timepoints for the analysis of AUC0-tlast. PK parameters will be determined by non-compartmental analysis.

Time to Reach Maximum Concentration (tmax) for Paracetamol ODT (Test) Vs Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period

Blood samples will be collected at indicated timepoints for the analysis of tmax. PK parameters will be determined by non-compartmental analysis.

Cmax for Paracetamol ODT (Test) Vs Paracetamol (Pandol Film-coated Tablet) (Reference 2)
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period

Cmax is defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples will be collected at indicated timepoints for the analysis of Cmax. PK parameters will be determined by non-compartmental analysis.

AUC0-tlast for Paracetamol ODT (Test) Vs Paracetamol (Pandol Film-coated Tablet) (Reference 2)
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period

AUC0-tlast is defined as area under the concentration Vs time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations. Blood samples will be collected at indicated timepoints for the analysis of AUC0-tlast). PK parameters will be determined by non-compartmental analysis.

tmax for Paracetamol ODT (Test) Vs Paracetamol (Pandol Film-coated Tablet) (Reference 2)
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period

Blood samples will be collected at indicated timepoints for the analysis of tmax. PK parameters will be determined by non-compartmental analysis.

Secondary Endpoints
Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity [AUC (0-inf)] for Paracetamol ODT (Test)
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC (0-inf) for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC (0-inf) for Paracetamol (Pandol Film-coated Tablet) (Reference 2)
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Test ProductEXPERIMENTALParticipants will be randomly assigned as per cross-over design to receive oral administration of one paracetamol ODT (test product) on day 1 of period 1, one Alvedon film-coated tablet (reference product 1) on day 1 of period 2 and one Panadol film-coated tablet (reference product 2) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days).
Reference Product 1ACTIVE_COMPARATORParticipants will be randomly assigned as per cross-over design to receive oral administration of one Alvedon film-coated tablet (reference product 1) on day 1 of period 1, one Panadol film-coated tablet (reference product 2) on day 1 of period 2 and one paracetamol ODT (test product) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days).
Reference Product 2ACTIVE_COMPARATORParticipants will be randomly assigned as per cross-over design to receive oral administration of one Panadol film-coated tablet (reference product 2) on day 1 of period 1, and one paracetamol ODT (test product) on day 1 of period 2 and one Alvedon film-coated tablet (reference product 1) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days).
Interventions
NameTypeDescription
Paracetamol ODTDRUGExperimental Paracetamol 500 mg ODT
Alvedon film-coated tabletDRUGMarketed Paracetamol 500 mg film-coated tablet
Panadol film-coated TabletDRUGMarketed Paracetamol 500 mg film-coated tablet
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the participants participating in the clinical trial. * Sex: male/female. * Age: 18 to 55 years (including) * B...

Countries:Germany
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