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

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ClinicalTrials.gov Identifier: NCT00864006
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
Sandoz

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

Condition or disease Intervention/treatment Phase
Seizures Drug: Divalproex Sodium Drug: Depakote DR Tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : October 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Bioequivalence according to US FDA Guidelines [ Time Frame: 9 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864006


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

Responsible Party: Eric Mitleberg. Ph.D., VP Product Development, Sandoz, Inc.
ClinicalTrials.gov Identifier: NCT00864006     History of Changes
Other Study ID Numbers: 2006-1294
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2009

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Valproic Acid
Anticonvulsants
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