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

Sponsor

Teva Pharmaceuticals USA (Industry)

Overall Status

Completed

CT.gov ID

NCT00974012

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Divalproex Sodium Drug: Depakote®	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	PRACS Institute, Ltd.	East Grand Forks	Minnesota	United States	56721

Sponsors and Collaborators

Teva Pharmaceuticals USA

Investigators

Principal Investigator: James D Carlson, Pharm. D., PRACS Institute, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00974012

Other Study ID Numbers:

R06-0442

First Posted:

Sep 10, 2009

Last Update Posted:

Sep 10, 2009

Last Verified:

Sep 1, 2009

Keywords provided by , ,

Bioequivalence

Additional relevant MeSH terms:

Valproic Acid

Study Results

No Results Posted as of Sep 10, 2009