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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00834275 | Cefadroxil 500 mg Capsules Under Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | Sep 1, 2004 | Oct 1, 2004 | Aug 19, 2024 | 2 | United States, Canada |
| NCT00835081 | Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects. | PHASE1 | COMPLETED | 26 | — | — | Sep 1, 2004 | Oct 1, 2004 | Aug 19, 2024 | 2 | United States, Canada |
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 |
|---|---|---|
| Cefadroxil 500 mg Capsules | DRUG | 1 x 500 mg |
| DURICEF® capsules 500 mg | DRUG | 1 x 500 mg |
Inclusion Criteria: * Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening. * Body mass index (BMI= weight/height2 greater than or equal to 19kg/m2 and less than or equal to 30kg/m2. * Availability o...