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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Seizure

Treatments: Drug: Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc); Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946751

AA15241

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

1

Experimental group

Description:

Levetiracetam Tablets, 750 mg (Sandoz Inc.)

Treatment:

Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.)

2

Active Comparator group

Description:

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

Treatment:

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