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Epamin: Reference Drug

Phase 1

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

Epamin: Reference Drug 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 Enrollment32

FDA Designations

No designations recorded

Epamin: Reference Drug clinical trials

Epamin: Reference Drug · 1 trial · 1 indication

Phase 1 1
NCT01122940Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.Healthy
COMPLETED32 Analytics
PHASE1COMPLETED
Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.
Healthy
NCT0112294032
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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 to 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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