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Phenytoin

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 8, 2024

Target and mechanism

ModalitySmall molecule

Also known as Phenytoin (Ascoli)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment69

FDA Designations

No designations recorded

Clinical trial landscape

Phenytoin · 2 trials · 1 indication

Phase 1 2
NCT01122953Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting ConditionsHealthy
COMPLETED34 Analytics
NCT06466473A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy AdultsHealthy
COMPLETED35 Analytics
PHASE1COMPLETED
Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions
Healthy
NCT0112295334
Unlock trial analytics
PHASE1COMPLETED
A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults
Healthy
NCT0646647335
Unlock trial analytics

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
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
72 hours
Maximum Observed Plasma Concentration (Cmax) of Phenytoin
72 hours

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
Number of Participants With Adverse Events (AEs) According to Seriousness
Baseline, up to 35 days post last dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
PhenytoinEXPERIMENTAL -
EpaminACTIVE_COMPARATOR -
Phenytoin manufactured at Vega Baja siteACTIVE_COMPARATOR -
Phenytoin manufactored at Ascoli siteEXPERIMENTAL -

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
Phenytoin (Ascoli)DRUGPhenytoin 50mg chewable tablets
Phenytoin (Vega Baja)DRUGPhenytoin 50mg chewable tablets
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Eligibility Criteria

Age Range18 Years to 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:MexicoUnited States
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