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Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00864006
First received: March 17, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Seizures
 Drug: Divalproex Sodium
Drug: Depakote DR Tablets
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

Resource links provided by NLM:

MedlinePlus related topics: Seizures
U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence according to US FDA Guidelines [ Time Frame: 9 Days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Divalproex Sodium 125 MG Delayed Release Tablets Sandoz
 Drug: Divalproex Sodium
Active Comparator: 2
Depakote 125 MG DR Tablets Abbott Laboratories USA
 Drug: Depakote DR Tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864006

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Xueyu Chen, MD, Ph.D, FRCP(C) Pharma Medica Research, Inc.
  More Information

No publications provided

Responsible Party: Eric Mitleberg. Ph.D., VP Product Development, Sandoz, Inc.
ClinicalTrials.gov Identifier: NCT00864006     History of Changes
Other Study ID Numbers: 2006-1294
Study First Received: March 17, 2009
Last Updated: March 17, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013