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Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

NCT ID: NCT00864006

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2006-10-31

Brief Summary

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The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.

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Detailed Description

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Conditions

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Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Divalproex Sodium 125 MG Delayed Release Tablets Sandoz

Group Type EXPERIMENTAL

Divalproex Sodium

Intervention Type DRUG

2

Depakote 125 MG DR Tablets Abbott Laboratories USA

Group Type ACTIVE_COMPARATOR

Depakote DR Tablets

Intervention Type DRUG

Interventions

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Divalproex Sodium

Intervention Type DRUG

Depakote DR Tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No clinically significant findings on physical examination, medical history or laboratory tests on screening

Exclusion Criteria

* Positive test for HIV or Hepatitis B and C
* History of sensitivity to valproic acid or related compounds
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Sandoz, Inc.

Principal Investigators

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Xueyu Chen, MD, Ph.D, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

Pharma Medica Research, Inc.

Other Identifiers

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2006-1294

Identifier Type: -

Identifier Source: org_study_id

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