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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
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    March 17, 2009
    Last Updated
    March 27, 2017
    Sponsor
    Sandoz
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    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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