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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00864006

Enrollment

Registered

2009-03-18

Start date

2006-10-31

Completion date

2006-10-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizures

Brief summary

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

Interventions

DRUGDivalproex Sodium

DRUGDepakote DR Tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence according to US FDA Guidelines	9 Days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026