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Epamin: Reference Drug

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 27, 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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01122940Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.PHASE1 COMPLETED 32 — — Jul 1, 2010Aug 1, 2010Jan 27, 20211 Mexico
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Study Endpoints
Primary Endpoints
To prove the bioequivalence of Phenytoin versus Epamin by measuring; Area under the curve (AUC), Maximum Concentration (Cmax), Time maximum concentration (tmax), Constant of elimination (ke), Elimination half life (t1/2)
April 2010 - May 2010
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Epamin: McNeil LA LLCACTIVE_COMPARATOR -
Phenytoin: Laboratorios Pfizer SA DE CVEXPERIMENTAL -
Interventions
NameTypeDescription
Epamin: Reference DrugDRUGSingle dose of 75 mg (10 ml in suspension) of Epamin
Phenytoin: Study DrugDRUGSingle dose of 75 mg (10 ml in suspension) of Phenytoin
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive * A Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight \>50 kg (110 lbs) * An informed consent document signed and dated by the subject or ...

Countries:Mexico
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