CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
divalproex sodium +1 moredrug
Likely dose
divalproex sodium 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00834639
NCT00834639Phase 1Completed
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A Relative Bioavailability Study of 500 mg Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions

Teva Pharmaceuticals USA·interventional·Posted Feb 3, 2009·Updated Aug 20, 2009

In Brief

A Phase 1 clinical trial evaluating divalproex sodium and Depakote® for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets)in healthy subjects under fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2009
Enrollment StartSep 1, 2003
Primary CompletionSep 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago

Interventions

divalproex sodiumdrug

delayed-release 500 mg tablet

Depakote®drug

delayed-release 500 mg tablet