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A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia

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ClinicalTrials.gov Identifier: NCT01355068
Recruitment Status : Completed
First Posted : May 17, 2011
Results First Posted : December 14, 2011
Last Update Posted : December 14, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 12, 2011
First Posted Date  ICMJE May 17, 2011
Results First Submitted Date  ICMJE November 10, 2011
Results First Posted Date  ICMJE December 14, 2011
Last Update Posted Date December 14, 2011
Study Start Date  ICMJE May 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2011)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose ]
    Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2011)
  • Area under the curve from zero to the last measurable concentration of phenytoin (AUClast) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours postdose. ]
  • Peak plasma concentraiton of phenytoin (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours postdose. ]
Change History Complete list of historical versions of study NCT01355068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2011)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞]) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose ]
    AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
  • Extrapolated Area Under the Curve (AUC Percent [%] Extrap) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose ]
    AUC%extrap is the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as (AUC [0-∞] minus AUClast)*100/ AUC [0-∞], where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
  • Plasma Decay Half Life (t1/2) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2011)
  • Area under the curve from time zero to infinity (AUCinf) for phenytoin [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours postdose. ]
  • Extraolated area under the curve for phenytoin (AUC%extrap), [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours postdose. ]
  • Half life [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours postdose. ]
  • Time to peak plasma concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours postdose. ]
  • Adverse events [ Time Frame: 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
Official Title  ICMJE An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Epanutin Infatabs 50 mg (Sourced From Germany) Verses Dilantin Infatabs 50 mg (Sourced From Australia) in Healthy Subjects
Brief Summary In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a pivotal bioequivalence study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Epanutin Infatabs (Phenytoin)
    Chewable Tablet, 50 mg, Single dose
  • Drug: Dilantin Infatabs (Phenytoin)
    Chewable Tablet, 50 mg, Single dose
Study Arms  ICMJE
  • Active Comparator: Treatment A
    Epanutin Infatabs 50 mg (sourced from Germany), 1 x 50 mg (REFERENCE)
    Intervention: Drug: Epanutin Infatabs (Phenytoin)
  • Experimental: Treatment B
    Dilantin Infatabs 50 mg (sourced from Australia), 1 x 50 mg (TEST)
    Intervention: Drug: Dilantin Infatabs (Phenytoin)
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: May 16, 2011)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
  • An informed consent document signed and dated by the subject.

Exclusion Criteria:

  • Evidence or history of clinically significant abnormalities.
  • Any condition possibly affecting drug absorption (e.g. gastrectomy).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01355068
Other Study ID Numbers  ICMJE A4121010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2011

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