Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00974441
First received: September 9, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of Depakote® ER Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects administered under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Divalproex Sodium
Drug: Depakote®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of 500 mg Divalproex Sodium Extended Release Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area under the concentration-time curve from time zero to time of last quantifiable concentration (per participant) [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: August 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Divalproex Sodium
500 mg Extended Release Tablet
Drug: Divalproex Sodium
500 mg Extended Release Tablet
Active Comparator: Depakote®
500 mg Extended Release Tablet
Drug: Depakote®
500 mg Extended Release Tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Subjects who have completed the screening process within 28 days prior to Period 1 dosing
  • Subjects who are healthy adult men and women 18 years of age or older at the time of dosing.
  • Subjects who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weigh at least 110 lbs.
  • Subjects who are healthy as documented by the medical history, physical examination (including bur may not be limited to and evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files and agreed upon by both the study physician and investigator prior to enrolling the subject in this study and for continued enrollment.
  • Female subjects of postmenopausal (no menses) status for at least 1 year and has a serum FSH level greater than or equal to 30 mIU/mL or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).

Exclusion Criteria

  • Subjects who report receiving any investigational drug within 30 days prior to Period 1 dosing.
  • Subjects who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
  • Subjects whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
  • Subjects who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
  • Subjects who report a history or allergic response(s) to divalproex or related drugs.
  • Subjects who report the use of any systemic prescription medication in the 14 days prior to Period 1 dosing.
  • Subjects who report the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period 1 dosing.
  • Subjects who report a history of clinically significant allergies including drug allergies.
  • Subjects who report a clinically significant illness during the 4 weeks prior to Period 1 dosing (as determined by the clinical investigators).
  • Subjects who report a history of drug or alcohol addiction or abuse within the past year.
  • Subjects who demonstrate a positive drug abuse screen for this study prior to Period 1 administration.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974441

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D Carlson, Pharm. D PRACS Institute, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00974441     History of Changes
Other Study ID Numbers: R06-0441
Study First Received: September 9, 2009
Last Updated: September 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence

Additional relevant MeSH terms:
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 April 22, 2014