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

Sandoz30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy Bipolar Disorder

Interventions

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

Depakote 500 mg DR Tablets (Abbott Laboratories, USA)DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 10 days

Data from ClinicalTrials.gov

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