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Levothyroxine 300 μg

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as Levothyroxine Sodium Tablets 300 μg

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

Levothyroxine 300 μg · 2 trials · 1 indication

Phase 1 2
NCT00648700Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μgHealthy
COMPLETED32 Analytics
NCT00647855Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μgHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μg
HealthyUnlock trial analytics

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
Synthroid® Tablets 300 μgDRUG2x300mcg, single dose fasting
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Eligibility Criteria

Age Range18 Years to 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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