To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions

To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fed conditions.

Completed

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Key information

Conditions

Epilepsy Bipolar Disorder Bipolar and Related Disorders Brain Diseases Central Nervous System Diseases Mental Disorders Mood Disorders Nervous System Diseases

Age range

21 year–47 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.

Treatment and study plan

Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)

Drug

Depakote 500 mg DR Tablets (Abbott Laboratories, USA)

Drug

Primary outcomes

Bioequivalence based on AUC and Cmax

Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Jun 4, 2009
Registry last updated: Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed