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
Results First Received: November 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Healthy
Interventions: Drug: Epanutin Infatabs (Phenytoin)
Drug: Dilantin Infatabs (Phenytoin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg Single oral dose of Epanutin (phenytoin) infatabs 50 milligram (mg) chewable tablet in first intervention period; and single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in first intervention period; and single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.

Participant Flow for 3 periods

Period 1:   First Intervention Period
    Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg     Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg  
STARTED     13     13  
COMPLETED     13     11  
NOT COMPLETED     0     2  
Adverse Event                 0                 1  
Withdrawal by Subject                 0                 1  

Period 2:   Washout Period (at Least 7 Days)
    Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg     Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg  
STARTED     13     11  
COMPLETED     13     11  
NOT COMPLETED     0     0  

Period 3:   Second Intervention Period
    Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg     Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg  
STARTED     13     11  
COMPLETED     13     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Entire Study Population Includes participants randomized to receive Epanutin (phenytoin) infatabs 50 mg first and Dilantin (phenytoin) infatabs 50 mg first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Mean ± Standard Deviation
  31.8  ± 8.3  
Gender  
[units: participants]
 
Female     1  
Male     25  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01355068     History of Changes
Other Study ID Numbers: A4121010
Study First Received: May 12, 2011
Results First Received: November 10, 2011
Last Updated: November 10, 2011
Health Authority: SINGAPORE: Parkway Independent Ethics Committee