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Synthroid 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 Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Synthroid 300 μg · 1 trial · 1 indication

Phase 1 1
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 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_COMPARATORSynthroid® Tablets 300 μg

Interventions

NameTypeDescription
Levothyroxine Sodium 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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Frequently asked questions about Synthroid 300 μg

What is Synthroid 300 μg used for?

Synthroid 300 μg is a small molecule drug being developed by Viatris Inc. for use in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial involving 30 participants. The drug is being studied as a levothyroxine sodium tablet formulation.

Who makes Synthroid 300 μg?

Synthroid 300 μg is developed by Viatris Inc., a company traded under the ticker VTRS. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers. Viatris is conducting research on this levothyroxine sodium tablet formulation.

What phase is Synthroid 300 μg in?

Synthroid 300 μg is in Phase 1 clinical development. It has one completed trial with 30 participants, and no active trials are currently listed. The drug is being studied in healthy volunteers as a levothyroxine sodium tablet formulation.

What clinical trials is Synthroid 300 μg in?

Synthroid 300 μg has one completed clinical trial, NCT00647855, titled "Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μg." This Phase 1 study enrolled 30 healthy volunteers in the United States and was active-controlled.

Is Synthroid 300 μg FDA approved?

Synthroid 300 μg is an investigational drug currently in Phase 1 clinical development. It is not approved by the FDA, as it is still being studied in clinical trials. The drug has one completed trial in healthy volunteers, but no active trials are ongoing.