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Levothroid 300 μg

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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648700Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μgPHASE1 COMPLETED 32Aug 1, 2005Sep 1, 2005Apr 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
1EXPERIMENTALLevothyroxine Sodium Tablets 300 μg
2ACTIVE_COMPARATORLevothroid® Tablets 300 μg
Interventions
NameTypeDescription
Levothyroxine Sodium Tablets 300 μgDRUG2x300mcg, single dose fasting
Levothroid® Tablets 300 μgDRUG2x300mcg, single dose fasting
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18-50 years. 2. Sex: Men and/or non-pregnant, non-lactating women. 1. Women of childbearing potential must have negative serum β human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to of the study and on the evening prior to each dose ad...

Countries:United States
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