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Trial record 29 of 106 for:    PHENYTOIN

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Epanutin Infatabs (Phenytoin)
Drug: Dilantin Infatabs (Phenytoin)
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg
Hide Arm/Group Description 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. 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.
Period Title: First Intervention Period
Started 13 13
Completed 13 11
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             0             1
Period Title: Washout Period (at Least 7 Days)
Started 13 11
Completed 13 11
Not Completed 0 0
Period Title: Second Intervention Period
Started 13 11
Completed 13 11
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes participants randomized to receive Epanutin (phenytoin) infatabs 50 mg first and Dilantin (phenytoin) infatabs 50 mg first.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
31.8  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
1
   3.8%
Male
25
  96.2%
1.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Hide Description Area under the plasma concentration time-curve from zero (pre-dose) to the last measured 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Hide Arm/Group Description:
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 24 26
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
21380.0  (6043.0) 21370.0  (5571.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanutin Infatabs 50 mg, Dilantin Infatabs 50 mg
Comments Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 101.33
Confidence Interval (2-Sided) 90%
97.85 to 104.94
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Hide Arm/Group Description:
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 24 26
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
952.10  (229.25) 976.50  (214.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanutin Infatabs 50 mg, Dilantin Infatabs 50 mg
Comments Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 102.20
Confidence Interval (2-Sided) 90%
97.18 to 107.47
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])
Hide Description 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-∞).
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Arm/Group Title Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Hide Arm/Group Description:
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 23 25
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
21730.0  (6345.9) 21740.0  (5816.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanutin Infatabs 50 mg, Dilantin Infatabs 50 mg
Comments Natural log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 101.43
Confidence Interval (2-Sided) 90%
97.56 to 105.47
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Extrapolated Area Under the Curve (AUC Percent [%] Extrap)
Hide Description 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.
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Hide Arm/Group Description:
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 24 26
Geometric Mean (Standard Deviation)
Unit of Measure: Percent AUC
3.321  (4.884) 3.198  (4.805)
5.Secondary Outcome
Title Plasma Decay Half Life (t1/2)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Arm/Group Title Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Hide Arm/Group Description:
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 23 26
Mean (Standard Deviation)
Unit of Measure: hr
14.380  (3.247) 14.970  (4.777)
6.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Hide Arm/Group Description:
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 24 26
Median (Full Range)
Unit of Measure: hr
3.51
(1.00 to 5.00)
4.00
(1.00 to 6.00)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Hide Arm/Group Description Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period. Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
All-Cause Mortality
Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Epanutin Infatabs 50 mg Dilantin Infatabs 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/24 (16.67%)   2/26 (7.69%) 
Infections and infestations     
Upper respiratory tract infection * 1  1/24 (4.17%)  1/26 (3.85%) 
Nervous system disorders     
Dizziness * 1  1/24 (4.17%)  0/26 (0.00%) 
Headache * 1  2/24 (8.33%)  0/26 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash * 1  0/24 (0.00%)  1/26 (3.85%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01355068     History of Changes
Other Study ID Numbers: A4121010
First Submitted: May 12, 2011
First Posted: May 17, 2011
Results First Submitted: November 10, 2011
Results First Posted: December 14, 2011
Last Update Posted: December 14, 2011