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Epamin

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 Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01122953Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting ConditionsPHASE1 COMPLETED 34 — — Apr 1, 2010Jun 1, 2010Jan 27, 20211 Mexico
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Study Endpoints
Primary Endpoints
Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.
0-168 h
Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval.
0-168 h
Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed.
0-168 h
Secondary Endpoints
Constant of elimination (ke): Will be determined as the slope from the linear logarithmic regression of the terminal phase of the logarithmic graph of concentration over time.
0-168 h
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
PhenytoinEXPERIMENTAL -
EpaminACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PhenytoinDRUGSingle dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.
EpaminDRUGSingle dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC
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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 * 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 a legally ac...

Countries:Mexico
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