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Bioequivalence Study of Dr. Reddy's Divalproex Sodium Capsules (Sprinkle), 125 mg Under Fasting Conditions

NCT01055938 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2010-01-26

No results posted yet for this study

Summary

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Divalproex Sodium

Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • S Sai Krishna, MBBS · 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
2006-12-31
Primary Completion
2007-01-31
Completion
2007-03-31

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 NCT01055938 on ClinicalTrials.gov