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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Epilepsy; Bipolar Disorder

Treatments: Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA); Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913848

2005-1050

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 21 to 47 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

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

2

Active Comparator group

Description:

Depakote 500 mg DR Tablets (Abbott Laboratories, USA)

Treatment:

Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)