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Levetiracetam

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

Levetiracetam · 4 trials · 1 indication

Phase 1 4
NCT00859430Levetiracetam 1000 mg Under Non-Fasting ConditionsHealthy
COMPLETED22 Analytics
NCT00859521Levetiracetam 1000 mg Under Fasting ConditionsHealthy
COMPLETED30 Analytics
NCT00849485Levetiracetam 750 mg Tablets Under Non-Fasting ConditionsHealthy
COMPLETED22 Analytics
NCT00849862Levetiracetam 750 mg Tablets Under Fasting ConditionsHealthy
COMPLETED22 Analytics
PHASE1COMPLETED
Levetiracetam 1000 mg Under Non-Fasting Conditions
Healthy
NCT0085943022
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PHASE1COMPLETED
Levetiracetam 1000 mg Under Fasting Conditions
Healthy
NCT0085952130
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PHASE1COMPLETED
Levetiracetam 750 mg Tablets Under Non-Fasting Conditions
Healthy
NCT0084948522
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PHASE1COMPLETED
Levetiracetam 750 mg Tablets Under Fasting Conditions
Healthy
NCT0084986222
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Study Endpoints

Primary Endpoints

Cmax - Maximum Observed Concentration
Blood samples collected over 36 hour period

Bioequivalence based on Cmax

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Blood samples collected over 36 hour period

Bioequivalence based on AUC0-inf

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Blood samples collected over 36 hour period

Bioequivalence based on AUC0-t

AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Blood samples collected over 36 hour period

Bioequivalence based on AUC0-t

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
LevetiracetamEXPERIMENTALLevetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
Keppra®ACTIVE_COMPARATORKeppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period

Interventions

NameTypeDescription
LevetiracetamDRUG1000 mg Tablet
Keppra®DRUG1000 mg Tablet
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria All subjects must satisfy the following criteria to be considered for study participation: * Subject must be male or non-pregnant, non-breast-feeding female * Subject must be at least 18 years of age * Subject must have a Body Mass Index (BMI) between 19 and 30 kg/m2, inclusive,...

Countries:United StatesCanada
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