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1: Liothyronine

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Sep 16, 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_CONTROLLED
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00978055Fasting Study of Liothyronine Sodium Tablets (50 Mcg) to Cytomel® Tablets (50 Mcg)PHASE1 COMPLETED 31Oct 1, 2007Dec 1, 2007Sep 16, 20091 United States
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Study Endpoints
Primary Endpoints
Bioequivalence
within 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALLiothyronine Sodium Tablets, 50 mcg
2ACTIVE_COMPARATORCytomel® Tablets, 50 mcg
Interventions
NameTypeDescription
1: Liothyronine Sodium TabletsDRUGLiothyronine Sodium Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting
2: Cytomel® TabletsDRUGCytomel® Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy males and/or non-pregnant, non-lactating females, 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 prior to start of study...

Countries:United States
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