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Trial record 2 of 4 for:    PHENYTOIN | ( Map: Mexico )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01122940
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : January 14, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 20, 2010
First Posted Date  ICMJE May 13, 2010
Last Update Posted Date January 14, 2011
Study Start Date  ICMJE July 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2010)
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) [ Time Frame: April 2010 - May 2010 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01122940 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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.
Detailed Description Bioequivalence
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 Date August 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP