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Rabeprazole

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 Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Rabeprazole · 1 trial · 1 indication

Phase 1 1
NCT00649493Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mgHealthy
COMPLETED72 Analytics
PHASE1COMPLETED
Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg
Healthy
NCT0064949372
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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 24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRabeprazole Sodium Tablets 20 mg
2ACTIVE_COMPARATORAciphex® Tablets 20 mg

Interventions

NameTypeDescription
Rabeprazole Sodium Tablets 20 mgDRUG20mg, single dose fed
Aciphex® Tablets 20 mgDRUG20mg, single dose fed
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Eligibility Criteria

Age Range8 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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