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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00865176 | Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 60 | — | — | Jun 1, 2006 | Jul 1, 2006 | Mar 29, 2017 | - | — |
| NCT00865618 | Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions | PHASE1 | COMPLETED | 60 | — | — | Jun 1, 2006 | Jul 1, 2006 | Mar 29, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Eplerenone 50mg Tablets |
| 2 | ACTIVE_COMPARATOR | INSPRA 50mg Tablets |
| Name | Type | Description |
|---|---|---|
| Eplerenone 50 mg Tablets Sandoz Inc., USA | DRUG | - |
| Inspra 50 mg Tablets GD Searle LLC, USA | 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.