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Levothyroxine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | LEVOTHYROXINE SODIUM TABLETS,USP 300 mcg; |
| 2 | ACTIVE_COMPARATOR | SYNTHROID® 300 mcg Tablets |
| Name | Type | Description |
|---|---|---|
| LEVOTHYROXINE SODIUM TABLETS, | DRUG | 2x300mcg, single dose fasting |
| SYNTHROID® 300 mcg Tablets | DRUG | 2x300mcg, single dose fasting |
| Levothyroxine Sodium Tablets 200 mg | DRUG | 3x200mcg, single dose fasting |
| Synthroid Tablets 200 mg | DRUG | 3x200mcg, 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 is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is a synthetic form of the thyroid hormone thyroxine, used as replacement therapy in conditions where the thyroid gland does not produce enough hormone. The specific indication for this product is undisclosed.
Levothyroxine works as an agonist at the thyroid hormone receptors THRA and THRB. By binding to and activating these nuclear receptors, it mimics the action of endogenous thyroid hormones, which regulate metabolism, growth, and development. This mechanism underlies its use as hormone replacement therapy.
Levothyroxine is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the development and manufacture of this particular levothyroxine sodium tablet product.
Levothyroxine is in Phase 1 clinical development. The two registered trials for this product are both Phase 1 studies, and both have been completed. No active trials are currently listed, and the drug has not been approved by the FDA for the undisclosed indication.
Levothyroxine has been studied in two completed Phase 1 trials: NCT00648882, which compared levothyroxine sodium 300 mcg tablets to Synthroid 300 mcg tablets in 33 healthy volunteers, and NCT00648557, which compared the 200 mg tablets to Synthroid 200 mg in 32 healthy volunteers. Both were active-controlled fasting studies conducted in the United States.