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Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.

Last updated on November 7, 2019

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Study Location
Pfizer Investigational Site
Mexico, Distrito Federal, 14050 Mexico
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01122940
Pfizer
Completed
Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.

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Descriptive Information
Brief Title  ICMJE Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.
Official Title  ICMJE 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.
Brief SummaryMexican 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.
Detailed DescriptionBioequivalence
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Epamin: Reference Drug
    Single dose of 75 mg (10 ml in suspension) of Epamin
  • Drug: Phenytoin: Study Drug
    Single dose of 75 mg (10 ml in suspension) of Phenytoin
Study Arms  ICMJE
  • Active Comparator: Epamin: McNeil LA LLC
    Intervention: Drug: Epamin: Reference Drug
  • Experimental: Phenytoin: Laboratorios Pfizer SA DE CV
    Intervention: Drug: Phenytoin: Study Drug
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2011)
32
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2010)
34
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion DateAugust 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01122940
Other Study ID Numbers  ICMJE A4121008
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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