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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Seizures

Treatments: Drug: Divalproex Sodium; Drug: Depakote DR Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00864006

2006-1294

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

1

Experimental group

Description:

Divalproex Sodium 125 MG Delayed Release Tablets Sandoz

Treatment:

Drug: Divalproex Sodium

2

Active Comparator group

Description:

Depakote 125 MG DR Tablets Abbott Laboratories USA

Treatment:

Drug: Depakote DR Tablets