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Finasteride

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 Trials2
Total Enrollment59
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00650377Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mgPHASE1 COMPLETED 30Oct 1, 2004Oct 1, 2004Apr 23, 20241 United States
NCT00648791Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mgPHASE1 COMPLETED 29Sep 1, 2004Oct 1, 2004Apr 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
1EXPERIMENTALFinasteride Tablets 5 mg
2ACTIVE_COMPARATORProscar® Tablets 5 mg
Interventions
NameTypeDescription
Finasteride Tablets 5 mgDRUG5mg, single dose fed
Proscar® Tablets 5 mgDRUG5mg, single dose fed
Proscar Tablets 5 mgDRUG5mg, single dose fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older 2. Sex: Male During the course of the study, from study screen until study exit, male volunteers must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their sexual partner. This advice should be documented in the ...

Countries:United States
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