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Levothyroxine 300 μg · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Levothyroxine Sodium Tablets 300 μg |
| 2 | ACTIVE_COMPARATOR | Levothroid® Tablets 300 μg |
| Name | Type | Description |
|---|---|---|
| Levothyroxine Sodium Tablets 300 μg | DRUG | 2x300mcg, single dose fasting |
| Levothroid® Tablets 300 μg | DRUG | 2x300mcg, single dose fasting |
| Synthroid® Tablets 300 μg | DRUG | 2x300mcg, single dose fasting |
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...
Levothyroxine 300 μg is a small molecule formulation of levothyroxine sodium developed by Viatris Inc. (ticker VTRS). It is also known as Levothyroxine Sodium Tablets 300 μg. The product is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed.
Levothyroxine 300 μg targets the thyroid hormone receptors THRA and THRB, where it acts as an agonist. By binding and activating these nuclear receptors, the drug mimics the action of endogenous thyroid hormone. This mechanism underlies its evaluation as a levothyroxine sodium tablet formulation.
Levothyroxine 300 μg is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor responsible for the clinical development of Levothyroxine Sodium Tablets 300 μg.
Levothyroxine 300 μg is in Phase 1 clinical development. It is an investigational product and is not approved. Two Phase 1 trials have been completed, with no active trials ongoing, and total enrollment across those completed studies was 62 participants.
Levothyroxine 300 μg has been studied in two completed Phase 1 trials: NCT00648700, which compared Levothyroxine Sodium Tablets 300 μg with Levothroid Tablets 300 μg in 32 healthy volunteers, and NCT00647855, which compared it with Synthroid Tablets 300 μg in 30 healthy volunteers. Both were conducted in the United States.