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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355068
First Posted: May 17, 2011
Last Update Posted: December 14, 2011
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.
Information provided by (Responsible Party):
Pfizer
May 12, 2011
May 17, 2011
November 10, 2011
December 14, 2011
December 14, 2011
May 2011
June 2011   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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. ]
Complete list of historical versions of study NCT01355068 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Epanutin Infatabs (Phenytoin)
    Chewable Tablet, 50 mg, Single dose
  • Drug: Dilantin Infatabs (Phenytoin)
    Chewable Tablet, 50 mg, Single dose
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2011
June 2011   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01355068
A4121010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

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