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Topiramate liquid formulation; Topiramate Sprinkle formulation

Phase 1

Epilepsy | Small molecule | Neurology |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Topiramate liquid formulation; Topiramate Sprinkle formulation · 1 trial · 1 indication

Phase 1 1
NCT00701493A Phase 1 Bioavailability Study of Topiramate Oral Liquid Formulation Compared to the Marketed Sprinkle Capsule Formulation in Healthy AdultsEpilepsy
COMPLETED40 Analytics
PHASE1COMPLETED
A Phase 1 Bioavailability Study of Topiramate Oral Liquid Formulation Compared to the Marketed Sprinkle Capsule Formulation in Healthy Adults
EpilepsyUnlock trial analytics

Study Endpoints

Primary Endpoints

AUClast, AUC¥, and Cmax (Area Under the Curve (last), Area Under the Curve (infinity) and maximum plasma concentration); Incidence, severity, and type of adverse event changes in laboratory results, physical exam, ECG, vital signs.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Topiramate oral liquid formulation;Topiramate Sprinkle formulationDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Body mass index (BMI) between 19 and 32 kg/m2, inclusive * Women of non-child-bearing potential or practicing birth control * Have a normal electrocardiogram (ECG) * Be in good health, in the opinion of the investigator * Be sufficiently alert to understand and communicate int...

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