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

Phase 1

Completed

• Conditions: Seizure
• Interventions: Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.); Drug: Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

• Registration Number: NCT00946751
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Levetiracetam Tablets, 750 mg (Sandoz Inc.)	Levetiracetam Tablets, 750 mg (Sandoz Inc.)
2	Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)	Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	10 days