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Trial record 8 of 372 for:    under | North Dakota, United States

Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00834639
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : August 4, 2009
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: divalproex sodium
Drug: Depakote®
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Divalproex Sodium First Depakote® First
Hide Arm/Group Description 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. 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.
Period Title: First Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Washout of 7 Days
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Second Intervention
Started 12 12
Completed 12 10
Not Completed 0 2
Reason Not Completed
Physician Decision             0             2
Arm/Group Title Divalproex Sodium First Depakote® First Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
0
   0.0%
1
   8.3%
1
   4.2%
Male
12
 100.0%
11
  91.7%
23
  95.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Black 1 1 2
White 11 10 21
Hispanic 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Cmax (Maximum Observed Concentration)
Hide Description Bioequivalence based on Cmax.
Time Frame Blood samples collected over a 72 hour period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Divalproex Sodium Depakote®
Hide Arm/Group Description:
500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: µg/mL
53.89  (5.15) 55.19  (5.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Divalproex Sodium, Depakote®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 97.36
Confidence Interval 90%
93.68 to 101.18
Estimation Comments 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%.
2.Primary Outcome
Title AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Hide Description Bioequivalence based on AUC0-t.
Time Frame Blood samples collected over a 72 hour period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Divalproex Sodium Depakote®
Hide Arm/Group Description:
500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: µg*h/mL
905.18  (195.96) 898.24  (205.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Divalproex Sodium, Depakote®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 100.59
Confidence Interval 90%
97.07 to 104.24
Estimation Comments 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%.
3.Primary Outcome
Title AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Hide Description Bioequivalence based on AUC0-inf.
Time Frame Blood samples collected over a 72 hour period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Divalproex Sodium Depakote®
Hide Arm/Group Description:
500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: µg*h/mL
982.25  (223.64) 978.75  (235.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Divalproex Sodium, Depakote®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 100.36
Confidence Interval 90%
97.35 to 103.46
Estimation Comments 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%.
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 Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Name/Title: Manager, Biopharmaceutics
Organization: TEVA Pharmaceuticals USA
Phone: 1-866-384-5525
ClinicalTrials.gov Identifier: NCT00834639     History of Changes
Other Study ID Numbers: R03-592
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: June 22, 2009
Results First Posted: August 4, 2009
Last Update Posted: August 20, 2009