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Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg

NCT00647712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2009-09-25

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Divalproex Sodium Extended-Release Tablets 500 mg

500mg, single dose fasting

DRUG

Depakote ER® Tablets 500 mg

500mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Daniel Freeland, D.O. · Cedra Clinical Research, LLC.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • United States

Study Locations

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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 NCT00647712 on ClinicalTrials.gov