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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00881426 | To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | Mar 1, 2004 | Apr 1, 2004 | Mar 29, 2017 | - | — |
| NCT00881855 | To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions | PHASE1 | COMPLETED | 35 | — | — | Mar 1, 2004 | Apr 1, 2004 | Mar 29, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Cefprozil 500 mg Tablets (Sandoz GmbH) |
| 2 | ACTIVE_COMPARATOR | Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb) |
| Name | Type | Description |
|---|---|---|
| Cefprozil 500 mg Tablets (Sandoz GmbH) | DRUG | - |
| Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb) | DRUG | - |
| Cefprozil 500 mg Tablets (Sandoz, GmbH) | DRUG | - |
| Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, 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.