Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions
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
1 other identifier
interventional
34
1 country
1
Brief Summary
To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Apr 2010
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 29, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJanuary 27, 2021
July 1, 2010
2 months
April 29, 2010
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
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
Study Arms (2)
Phenytoin
EXPERIMENTALEpamin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
Mexico City, Mexico City, 14050, Mexico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2010
First Posted
May 13, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
January 27, 2021
Record last verified: 2010-07