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

NCT00913874 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-03-28

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

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

DRUG

Depakote 500 mg DR Tablets (Abbott Laboratories, USA)

Sponsors & Collaborators

Principal Investigators

  • Xueya (Eric) Chen, M.D. · Pharma Medica Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2005-10-31
Completion
2005-10-31

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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 NCT00913874 on ClinicalTrials.gov