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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00834795 | Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects | PHASE1 | COMPLETED | 36 | — | — | Dec 1, 2001 | Dec 1, 2001 | Aug 19, 2024 | 1 | United States |
| NCT00834873 | Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects | PHASE1 | COMPLETED | 24 | — | — | Dec 1, 2001 | Dec 1, 2001 | Aug 19, 2024 | 1 | United States |
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. ...