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Levetiracetam

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 14, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Levetiracetam · 2 trials · 1 indication

Phase 1 2
NCT01131897Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting Conditions.Healthy
COMPLETED24 Analytics
NCT01132352Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed ConditionsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting Conditions.
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioavailability based on Cmax and AUC parameters
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LevetiracetamEXPERIMENTALLevetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Keppra®ACTIVE_COMPARATORKeppra® 750 mg Tablets of UCB Pharma Inc.,

Interventions

NameTypeDescription
LevetiracetamDRUGLevetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult male volunteers, 18 to 55 years of age; * Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983); * Medically healthy subjects with clinically normal laboratory profiles and...

Countries:United States
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