NCT00864006

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

Same day

First QC Date

March 17, 2009

Last Update Submit

March 27, 2017

Conditions

Seizures

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA Guidelines

    9 Days

Study Arms (2)

1

EXPERIMENTAL

Divalproex Sodium 125 MG Delayed Release Tablets Sandoz

Drug: Divalproex Sodium

2

ACTIVE COMPARATOR

Depakote 125 MG DR Tablets Abbott Laboratories USA

Drug: Depakote DR Tablets

Interventions

Divalproex SodiumDRUG
1
Depakote DR TabletsDRUG
2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No clinically significant findings on physical examination, medical history or laboratory tests on screening

You may not qualify if:

  • Positive test for HIV or Hepatitis B and C
  • History of sensitivity to valproic acid or related compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Seizures

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Xueyu Chen, MD, Ph.D, FRCP(C)

    Pharma Medica Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

October 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

March 29, 2017

Record last verified: 2009-03