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Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00834639
First received: January 30, 2009
Last updated: August 14, 2009
Last verified: August 2009
History of Changes
Results First Received: June 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: divalproex sodium
Drug: Depakote®

  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
No text entered.

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
Divalproex Sodium First 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
Depakote® First 500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.

Participant Flow for 3 periods

 Period 1:   First Intervention
    Divalproex Sodium First     Depakote® First  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  

Period 2:   Washout of 7 Days
    Divalproex Sodium First     Depakote® First  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Divalproex Sodium First     Depakote® First  
STARTED     12     12  
COMPLETED     12     10  
NOT COMPLETED     0     2  
Physician Decision                 0                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Divalproex Sodium First 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
Depakote® First 500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
    Divalproex Sodium First     Depakote® First     Total  
Number of Participants  
[units: participants]
 		  12     12     24  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     0     1     1  
Male     12     11     23  
Race/Ethnicity, Customized  
[units: participants]
 		     
Black     1     1     2  
White     11     10     21  
Hispanic     0     1     1  
Region of Enrollment  
[units: participants]
 		     
United States     12     12     24  



  Outcome Measures
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1.  Primary:   Cmax (Maximum Observed Concentration)   [ Time Frame: Blood samples collected over a 72 hour period. ]
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2.  Primary:   AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 72 hour period. ]
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3.  Primary:   AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 72 hour period. ]
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Measure Type Primary
Measure Title AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Measure Description Bioequivalence based on AUC0-inf.
Time Frame Blood samples collected over a 72 hour period.  
Safety Issue No  

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.
All participants that completed the study had their samples analyzed.

Reporting Groups
  Description
Divalproex Sodium 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
Depakote® 500 mg Depakote® Delayed Release Tablets reference product dosed in either period.

Measured Values
    Divalproex Sodium     Depakote®  
Number of Participants Analyzed  
[units: participants]
 		  22     22  
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)  
[units: µg*h/mL]
Mean ± Standard Deviation 		  982.25  ± 223.64     978.75  ± 235.36  


Statistical Analysis 1 for AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Ratio of the T/R geometric mean x 100 [3] 100.36
90% Confidence Interval ( 97.35 to 103.46 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.
[3] Other relevant estimation information:
  Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.




  Serious Adverse Events
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  Other Adverse Events
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  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: Manager, Biopharmaceutics
Organization: TEVA Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com


No publications provided


ClinicalTrials.gov Identifier: NCT00834639     History of Changes
Other Study ID Numbers: R03-592
Study First Received: January 30, 2009
Results First Received: June 22, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board