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NCT00864006 Clinical Trial

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

Seizures Clinical Trial

Official title:
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00864006
Other study ID # 2006-1294
Secondary ID
Status Completed
Phase Phase 1
First received March 17, 2009
Last updated March 27, 2017
Start date October 2006
Est. completion date October 2006

Study information
Verified date March 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Divalproex Sodium

• Depakote DR Tablets

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sandoz

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence according to US FDA Guidelines 9 Days
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