Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Epamin: Reference Drug (Drug); Phenytoin: Study Drug (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
Mexican healthy volunteers will receive the current form of the drug (under the name of
Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.
Clinical Details
Official title: Bioequivalence Study Of 10ml Dose Of Phenytoin 0.75g/100ml Suspension Made By Laboratorios Pfizer, S.A. De C.V. Versus Epamin® 0.75g/100ml Made By McNeil LA LLC, Study In 34 Healthy Volunteers Under Fasting Conditions.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: 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)
Detailed description:
Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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 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.
Locations and Contacts
Pfizer Investigational Site, Mexico, Distrito Federal 14050, Mexico
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: July 2010
Last updated: January 13, 2011
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