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Epanutin Infatabs

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 28, 2021

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_CONTROLLED
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01355068A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From AustraliaPHASE1 COMPLETED 26 — — May 1, 2011Jun 1, 2011Jan 28, 20211 Singapore
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Study Endpoints
Primary Endpoints
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose

Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).

Maximum Observed Plasma Concentration (Cmax)
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Secondary Endpoints
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Extrapolated Area Under the Curve (AUC Percent [%] Extrap)
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Plasma Decay Half Life (t1/2)
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment AACTIVE_COMPARATOREpanutin Infatabs 50 mg (sourced from Germany), 1 x 50 mg (REFERENCE)
Treatment BEXPERIMENTALDilantin Infatabs 50 mg (sourced from Australia), 1 x 50 mg (TEST)
Interventions
NameTypeDescription
Epanutin Infatabs (Phenytoin)DRUGChewable Tablet, 50 mg, Single dose
Dilantin Infatabs (Phenytoin)DRUGChewable Tablet, 50 mg, Single dose
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. * An informed consent document signed and dated by the subject. Exclusion Criteria: * Evidence or history of clinically significant abnormalities. * Any condition possibly affecting drug abso...

Countries:Singapore
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