Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARAVA · 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 |
|---|---|---|
| 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...
ARAVA is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with one completed clinical trial involving 37 participants.
ARAVA is being investigated for use in healthy individuals. It is not approved for any specific disease or condition. The drug is in early-stage clinical development, and its potential therapeutic applications have not been established.
ARAVA is developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. Teva is responsible for the clinical development of this drug.
ARAVA is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently ongoing. The drug is still in the investigational stage and has not been approved by regulatory authorities.
ARAVA has been studied in one clinical trial with the identifier NCT00834405. This trial, titled 'Leflunomide 20 mg Tablets, Non-Fasting,' was a Phase 1 study in healthy volunteers in the United States. The trial has been completed.