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Femara

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Dec 1, 2009

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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648063Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mgPHASE1 COMPLETED 24 — — Nov 1, 2005Jan 1, 2006Dec 1, 20091 United States
NCT00648154Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mgPHASE1 COMPLETED 24 — — Nov 1, 2005Jan 1, 2006Dec 1, 20091 United States
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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 216 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALLetrozole Tablets 2.5 mg
2ACTIVE_COMPARATORFemara® Tablets 2.5 mg
Interventions
NameTypeDescription
Letrozole Tablets 2.5 mgDRUG2.5mg, single dose fasting
Femara® Tablets 2.5 mgDRUG2.5mg, single dose fasting
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Eligibility Criteria
Age Range40 Years — N/A
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 40 years or older. 2. Sex: Females only. 3. Weight: At least 52 kg (115 lbs) and within 30% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HU...

Countries:United States
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