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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01355068
First received: May 12, 2011
Last updated: November 10, 2011
Last verified: November 2011

May 12, 2011
November 10, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Half life [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours postdose. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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).
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01355068
A4121010
No
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