Recent Updates
Recently added Catalysts

Keppra

Phase 1

Seizure | Small molecule | Neurology |Novartis AG|Last Updated: Mar 28, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Keppra · 1 trial · 1 indication

Phase 1 1
NCT00946751To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting ConditionsSeizure
COMPLETED20 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions
Seizure
NCT0094675120
Unlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
10 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLevetiracetam Tablets, 750 mg (Sandoz Inc.)
2ACTIVE_COMPARATORKeppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

Interventions

NameTypeDescription
Levetiracetam Tablets, 750 mg (Sandoz Inc.)DRUG -
Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

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.

Unlock Eligibility Criteria