Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions

A Relative Bioavailability Study of 500 mg Divalproex Sodium Extended Release Tablets Under Non-Fasting Conditions

This study was designed to compare the relative bioavailability (rate and extent of absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy, adult subjects under non-fasting conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Divalproex Sodium; Drug: Depakote®

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • East Grand Forks, Minnesota, United States, 56721
      • PRACS Institute, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Divalproex Sodium; 500 mg Extended Release Tablet	Drug: Divalproex Sodium; 500 mg ER Tablet
Active Comparator: Depakote®; 500 mg Extended Release Tablet	Drug: Depakote®; 500 mg ER Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax - Maximum Observed Concentration	Blood samples collected over 72 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)	Blood samples collected over 72 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last quantifiable concentration (per participant)	Blood samples collected over 72 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: September 9, 2009
• First Submitted That Met QC Criteria: September 9, 2009
• First Posted (Estimate): September 10, 2009

Study Record Updates

• Last Update Posted (Estimate): September 10, 2009
• Last Update Submitted That Met QC Criteria: September 9, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; GABA Agents; Anticonvulsants; Antimanic Agents; Valproic Acid
• Other Study ID Numbers: R06-0442