Back to resultsTo Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions
Primary Purpose
Epilepsy, Bipolar Disorder
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00913874
Brief Title
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions
Official Title
A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fasting conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
Intervention Type
Drug
Intervention Name(s)
Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
10 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueya (Eric) Chen, M.D.
Organizational Affiliation
Pharma Medica Research, Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions
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