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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00834405 | Leflunomide 20 mg Tablets, Non-Fasting | PHASE1 | COMPLETED | 37 | — | — | Apr 1, 2002 | May 1, 2002 | Aug 19, 2024 | 2 | United States |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
| Arm | Type | Description |
|---|---|---|
| Leflunomide | EXPERIMENTAL | Leflunomide 20 mg Tablet |
| Arava® | ACTIVE_COMPARATOR | Arava® 20 mg Tablet |
| Name | Type | Description |
|---|---|---|
| ARAVA® 20 mg tablets | DRUG | 1 x 20 mg, single-dose non-fasting |
| Leflunomide 20 mg Tablets | DRUG | 1 x 20 mg, single-dose non-fasting |
Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. Females must be physically unable to become pregnant. Males must be vasectomized. Weight of the subjects shall not be more than 20% ± from normal for height and body frame (Metropolitan Life, 19...