NCT01122953CompletedPhase 1
Bioequivalence Study Of 5ml Dose Of PHENYTOIN 125mg/ 5ml Suspension Made By Laboratorios Pfizer, S.A. De C.V. Versus EPAMIN® 125 mg/5ml Made By McNeil LA LLC, Study In Healthy Volunteers Under Fasting Conditions
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country34 target enrollmentStarted: April 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.
Study Overview
Brief Summary
To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.
Detailed Description
Bioequivalence study in healthy volunteers
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 acceptable representative.
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
Arms & Interventions
Phenytoin
Experimental
Intervention: Phenytoin (Drug)
Epamin
Active Comparator
Intervention: Epamin (Drug)
Outcomes
Primary Outcomes
Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.
Time Frame: 0-168 h
Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval.
Time Frame: 0-168 h
Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed.
Time Frame: 0-168 h
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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