Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00648882 | Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcg | PHASE1 | COMPLETED | 33 | — | — | Mar 1, 2007 | May 1, 2007 | Apr 24, 2024 | 1 | United States |
| NCT00648557 | Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg | PHASE1 | COMPLETED | 32 | — | — | Jan 1, 2003 | Mar 1, 2003 | Apr 24, 2024 | 1 | United States |
| 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...