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

Epilepsy Clinical Trial

Official title:

A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913874
• Other study ID #: 2005-1049
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2009
• Last updated: March 27, 2017
• Start date: October 2005
• Est. completion date: October 2005

Study information

• Verified date: June 2009
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Epilepsy

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on AUC and Cmax		10 days