Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions

NCT ID: NCT00826865

Last Updated: 2018-01-23

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

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2005-08-31

Brief Summary

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The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets under fasted conditions

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

Interventions

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Levetiracetam

750 mg tablet

Intervention Type DRUG

Other Intervention Names

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KEPPRA

Eligibility Criteria

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Inclusion Criteria

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Roxane Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Roxane Laboratories, Inc.

Principal Investigators

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Mark Allison, MD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

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MDS Pharma Services

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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LEVE-T750-PVFS-1

Identifier Type: -

Identifier Source: org_study_id

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