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Topiramate 2 x

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Sep 23, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Topiramate 2 x · 1 trial · 1 indication

Phase 1 1
NCT00905567Topiramate 25 mg Tablets Under Fed ConditionsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Topiramate 25 mg Tablets Under Fed Conditions
Healthy
NCT0090556724
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Study Endpoints

Primary Endpoints

Cmax - Maximum Observed Concentration
Blood samples collected over 96 hour period

Bioequivalence based on Cmax

AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)
Blood samples collected over 96 hour period

Bioequivalence based on AUC0-72

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Blood samples collected over 96 hour period

Bioequivalence based on AUC0-t

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Test FirstEXPERIMENTALTopiramate 2 x 25 mg Tablet
Reference FirstACTIVE_COMPARATORTopamax® Tablet 2 x 25 mg

Interventions

NameTypeDescription
Topiramate 2 x 25 mg tabletDRUG -
Topamax® Tablet 2 x 25 mgDRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Subjects will be females and/or males, non-smokers, 18 years of age or older * Subjects should read, sign and date an Informed Consent Form prior to any study procedures. * Female subjects will be post-menopausal or surgically sterilized. * Post menopausal status is defined as...

Countries:Canada
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