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Topiramate Sprinkle

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 23, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

Topiramate Sprinkle · 3 trials · 1 indication

Phase 1 3
NCT00648934Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mgHealthy
COMPLETED36 Analytics
NCT00649467Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mgHealthy
COMPLETED35 Analytics
NCT00649740Fasting Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mgHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
blood collections through 144 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTopiramate Sprinkle Capsules 25 mg
2ACTIVE_COMPARATORTopamax® Sprinkle Capsules 25 mg

Interventions

NameTypeDescription
Topiramate Sprinkle Capsules 25 mgDRUG25mg, single dose fed
Topamax® Sprinkle Capsules 25 mgDRUG25mg, single dose fed
Topamax® Sprinkle Capsule 25 mgDRUG25mg, single dose fasting
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Eligibility Criteria

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

Inclusion Criteria: * healthy, adult subjects, 18 years and older * able to swallow medication Exclusion Criteria: * institutionalized subjects * history of any significant disease * use of any prescription or OTC medications within 14 days of start of study * received any investigational product...

Countries:United States
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