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Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed Conditions

NCT01132196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2010-06-14

No results posted yet for this study

Summary

The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets 500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

Divalproex Sodium

Divalproex Sodium DR Tablets 500 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Mohanlal Siva Prasad Sayana · Bioserve Clinical Research Pvt. Ltd.,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2006-09-30
Completion
2006-11-30

Countries

  • India

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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 NCT01132196 on ClinicalTrials.gov