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Levothyroxine

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as LEVOTHYROXINE SODIUM TABLETS,

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

Levothyroxine · 2 trials · 1 indication

Phase 1 2
NCT00648882Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcgHealthy
COMPLETED33 Analytics
NCT00648557Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mgHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg
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,USP 300 mcg;
2ACTIVE_COMPARATORSYNTHROID® 300 mcg Tablets

Interventions

NameTypeDescription
LEVOTHYROXINE SODIUM TABLETS,DRUG2x300mcg, single dose fasting
SYNTHROID® 300 mcg TabletsDRUG2x300mcg, single dose fasting
Levothyroxine Sodium Tablets 200 mgDRUG3x200mcg, single dose fasting
Synthroid Tablets 200 mgDRUG3x200mcg, 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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