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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00834418 | Leflunomide 20 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 84 | — | — | Jun 1, 2002 | Jul 1, 2002 | Aug 20, 2024 | 1 | 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 |
|---|---|---|
| Leflunomide 20 mg Tablets | DRUG | 1 x 20 mg, single-dose fasting |
| ARAVA™ 20 mg Tablets | DRUG | 1 x 20 mg, single-dose fasting |
Inclusion Criteria: * Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight ...