Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions
Primary Purpose
Seizures
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Divalproex Sodium
Depakote DR Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Seizures
Eligibility Criteria
Inclusion Criteria:
- No clinically significant findings on physical examination, medical history or laboratory tests on screening
Exclusion Criteria:
- Positive test for HIV or Hepatitis B and C
- History of sensitivity to valproic acid or related compounds
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Divalproex Sodium 125 MG Delayed Release Tablets Sandoz
Depakote 125 MG DR Tablets Abbott Laboratories USA
Outcomes
Primary Outcome Measures
Bioequivalence according to US FDA Guidelines
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00864006
Brief Title
Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions
Official Title
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Divalproex Sodium 125 MG Delayed Release Tablets Sandoz
Arm Title
2
Arm Type
Active Comparator
Arm Description
Depakote 125 MG DR Tablets Abbott Laboratories USA
Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium
Intervention Type
Drug
Intervention Name(s)
Depakote DR Tablets
Primary Outcome Measure Information:
Title
Bioequivalence according to US FDA Guidelines
Time Frame
9 Days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No clinically significant findings on physical examination, medical history or laboratory tests on screening
Exclusion Criteria:
Positive test for HIV or Hepatitis B and C
History of sensitivity to valproic acid or related compounds
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueyu Chen, MD, Ph.D, FRCP(C)
Organizational Affiliation
Pharma Medica Research, Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions
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