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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00972855 | Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fed Conditions | PHASE1 | COMPLETED | 60 | — | — | Sep 1, 2003 | Sep 1, 2003 | Sep 9, 2009 | 1 | Canada |
| NCT00973050 | Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions | PHASE1 | COMPLETED | 60 | — | — | Sep 1, 2003 | Sep 1, 2003 | Sep 9, 2009 | 1 | Canada |
| Arm | Type | Description |
|---|---|---|
| Bicalutamide | EXPERIMENTAL | Bicalutamide 50 mg Tablet |
| Casodex® | ACTIVE_COMPARATOR | Casodex® 50 mg Tablet |
| Bicalutamide (test) | EXPERIMENTAL | Bicalutamide Tablet, 50 mg |
| Casodex® (reference) | ACTIVE_COMPARATOR | Casodex® Tablet, 50 mg |
| Name | Type | Description |
|---|---|---|
| Bicalutamide | DRUG | 50 mg Tablet |
| Casodex® | DRUG | 50 mg Tablet |
Inclusion Criteria: * Subjects will be males, non-smokers, 18 years of age and older. Exclusion Criteria: Subjects to whom any of the following applies will be excluded from the study: * Clinically significant illnesses within 4 weeks of the administration of study medication. * Clinically signi...