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

Phase 1CompletedNCT00864006

Sandoz28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Seizures

Interventions

Divalproex SodiumDRUG

Depakote DR TabletsDRUG

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bioequivalence according to US FDA Guidelines

Time frame: 9 Days

Data from ClinicalTrials.gov

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