Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Synthroid · 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...
Synthroid is a small molecule drug being developed by Viatris Inc. (VTRS) for use in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials studying its effects in healthy individuals. The drug is not approved for any specific disease indication.
Synthroid is developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy volunteers.
Synthroid is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved for any medical use.
Synthroid has two completed Phase 1 trials: NCT00648557, a fasting study comparing Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg, and NCT00648882, a fasting study comparing Levothyroxine Sodium Tablets 300 mcg to Synthroid Tablets 300 mcg. Both trials enrolled healthy adults in the United States.
Synthroid is a brand name for levothyroxine sodium. The clinical trials listed compare the generic levothyroxine sodium tablets to the Synthroid brand tablets, indicating they are intended to be bioequivalent formulations of the same active ingredient.