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Epamin

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Jan 27, 2021

Epamin development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Epamin clinical trials

Epamin · 1 trial · 1 indication

Phase 1 1
NCT01122953Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting ConditionsHealthy
COMPLETED34 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
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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 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:Mexico
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