Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Promethazine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Promethazine HCl 50 mg Tablets (Sandoz, Inc) |
| 2 | ACTIVE_COMPARATOR | Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) |
| Name | Type | Description |
|---|---|---|
| Promethazine HCl 50 mg Tablets (Sandoz, Inc) | DRUG | - |
| Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Promethazine is a small molecule drug being developed for allergy. It is currently in Phase 1 clinical development and is being studied as a treatment for allergic conditions. The drug is being developed by Novartis AG.
Promethazine is being developed by Novartis AG, a pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development for the treatment of allergy.
Promethazine is currently in Phase 1 clinical development. It is an investigational drug being studied for the treatment of allergy. The drug has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Promethazine has one completed clinical trial, NCT00947063, which was a Phase 1 study titled "To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions." The trial enrolled 36 participants and was conducted in healthy volunteers.
Promethazine is not FDA approved for the indication of allergy as it is still in Phase 1 clinical development. The drug is investigational and has not yet completed the clinical trials necessary to seek regulatory approval. Its safety and efficacy are still being evaluated.