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To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions

NCT ID: NCT00946751

Last Updated: 2017-03-28

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-03-31

Brief Summary

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To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.

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Detailed Description

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Conditions

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Seizure

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

Levetiracetam Tablets, 750 mg (Sandoz Inc.)

Group Type EXPERIMENTAL

Levetiracetam Tablets, 750 mg (Sandoz Inc.)

Intervention Type DRUG

2

Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

Group Type ACTIVE_COMPARATOR

Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

Intervention Type DRUG

Interventions

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Levetiracetam Tablets, 750 mg (Sandoz Inc.)

Intervention Type DRUG

Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

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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Gaetano Morelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Other Identifiers

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AA15241

Identifier Type: -

Identifier Source: org_study_id

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