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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00835354 | Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting | PHASE1 | COMPLETED | 26 | — | — | May 1, 2004 | May 1, 2004 | Aug 20, 2024 | 2 | United States |
| NCT00835614 | Cefprozil for Oral Suspension 250 mg/5 mL, Fasting | PHASE1 | COMPLETED | 26 | — | — | Apr 1, 2004 | Apr 1, 2004 | Aug 20, 2024 | 2 | United States |
| NCT00840866 | Cefprozil 500 mg Tablets Under Fed Conditions | PHASE1 | COMPLETED | 39 | — | — | Sep 1, 2003 | Sep 1, 2003 | Aug 20, 2024 | 1 | United States |
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Cefprozil for oral suspension 250 mg/5 mL | DRUG | 1 x 250 mg/5 mL, single-dose fasting |
| CEFZIL® for Oral Suspension 250 mg/5mL | DRUG | 1 x 250 mg/5 mL, single-dose fasting |
| cefprozil | DRUG | 500 mg Tablet |
| Cefzil® | DRUG | 500 mg Tablet |
Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less. * Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but i...