Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Carvedilol · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Carvedilol | EXPERIMENTAL | Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period |
| Coreg® | ACTIVE_COMPARATOR | Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Carvedilol 25 mg tablets | DRUG | 1 x 25 mg |
| COREG® 25 mg tablets | DRUG | 1 x 25 mg |
Inclusion Criteria: * Sex: Male of Female; similar proportions of each preferred. * Age: At least 18 years. * Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30. Exclusion Criteria: * Subjects not complying with the above inclusion criteria must be excluded from the study. ...
Carvedilol is a small molecule drug developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It is an antagonist that targets the alpha-1 adrenergic receptors ADRA1A, ADRA1D, and ADRA1B, as well as the beta-adrenergic receptors ADRB1, ADRB2, and ADRB3. Its therapeutic area is classified as Other, and the specific indications are undisclosed.
Carvedilol targets six adrenergic receptors: ADRA1A, ADRA1D, ADRA1B, ADRB1, ADRB2, and ADRB3. It acts as an antagonist at these targets. This receptor profile is characteristic of a combined alpha- and beta-blocker, though the clinical implications for its undisclosed indications are not specified.
Carvedilol is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor responsible for the clinical development of this small molecule drug.
Carvedilol is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication based on the available development information.
Carvedilol has been studied in two completed Phase 1 trials. NCT00834873 evaluated Carvedilol 25 mg in 24 fed, healthy adult subjects in the United States. NCT00834795 evaluated Carvedilol 25 mg in 36 fasted, healthy adult subjects, also in the United States. Both trials enrolled adults aged 18 years and older.