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A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets

NCT01898676 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-07-12

No results posted yet for this study

Summary

A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets.

Conditions

Interventions

DRUG

Divalproex Sodium Extended-release 250mg

Two tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods

DRUG

DEPAKOTE 250mg

Two tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods.

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Vince & Associates Clinical Research, Inc.

    lead OTHER

Principal Investigators

  • Bradley D. Vince, DO · Vince & Associates Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-08-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01898676 on ClinicalTrials.gov