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Aciphex

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648349Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mgPHASE1 COMPLETED 72May 1, 2003Jun 1, 2003Apr 24, 20241 United States
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Study Endpoints
Primary Endpoints
Bioequivalence
within 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALRabeprazole Sodium Delayed-Release Tablets 20 mg
2ACTIVE_COMPARATORAciphex® Delayed-Release Tablets 20 mg
Interventions
NameTypeDescription
Rabeprazole Sodium Delayed-Release Tablets 20 mgDRUG20mg, single dose fasting
Aciphex® Delayed-Release Tablets 20 mgDRUG20mg, single dose fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administratio...

Countries:United States
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