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

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

Completed

Looking for future studies?

Key information

Conditions

Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

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 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

Treatment and study plan

Divalproex Sodium

Drug

Depakote DR Tablets

Drug

Primary outcomes

Bioequivalence according to US FDA Guidelines

Time frame: 9 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 125 MG Delayed Release Tablets Under Fasting Conditions

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Mar 18, 2009
Registry last updated: Mar 29, 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