Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Leflunomide · 1 trial · 1 indication
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 ...
Leflunomide is a small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial evaluating a 20 mg tablet formulation under fasting conditions. The drug is being developed by Teva Pharmaceutical Industries Limited.
Teva Pharmaceutical Industries Limited (ticker: TEVA) is developing Leflunomide. The company is conducting clinical trials for this small molecule drug, which is currently in Phase 1 development.
Leflunomide is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
Leflunomide has one completed clinical trial, NCT00834418, titled "Leflunomide 20 mg Tablets Under Fasting Conditions." This Phase 1 study enrolled 84 healthy volunteers in the United States and was active-controlled, though not double-blinded.
Yes, Leflunomide is a small molecule drug. It is being developed by Teva Pharmaceutical Industries Limited and is currently in Phase 1 clinical trials for use in healthy volunteers.