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Levothroid 300 μg

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Levothroid 300 μg · 1 trial · 1 indication

Phase 1 1
NCT00648700Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μgHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
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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 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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Frequently asked questions about Levothroid 300 μg

What is Levothroid 300 μg used for?

Levothroid 300 μg is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial evaluating its effects in healthy adults. The drug is being developed by Viatris Inc.

Who makes Levothroid 300 μg?

Levothroid 300 μg is developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The drug is currently in Phase 1 clinical development for use in healthy volunteers.

What phase is Levothroid 300 μg in?

Levothroid 300 μg is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 32 healthy participants in the United States. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Levothroid 300 μg in?

Levothroid 300 μg has one completed clinical trial, registered as NCT00648700. This was a Phase 1 fasting study comparing Levothyroxine Sodium Tablets 300 μg to Levothroid Tablets 300 μg in 32 healthy adults in the United States.

Is Levothroid 300 μg the same as Levothyroxine Sodium?

Levothroid 300 μg is a levothyroxine sodium tablet formulation. The completed clinical trial NCT00648700 was a fasting study designed to compare Levothyroxine Sodium Tablets 300 μg with Levothroid Tablets 300 μg, indicating they are being evaluated for equivalence.