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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00882154 | To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions | PHASE1 | COMPLETED | 28 | — | — | Apr 1, 2005 | Apr 1, 2005 | Mar 29, 2017 | - | — |
| NCT00882700 | To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Apr 1, 2005 | Apr 1, 2005 | Mar 29, 2017 | - | — |
| NCT00883883 | To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions | PHASE1 | COMPLETED | 40 | — | — | Apr 1, 2005 | May 1, 2005 | Mar 29, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Cefdinir 300 mg Capsule (Sandoz, Austria) |
| 2 | ACTIVE_COMPARATOR | Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) |
| Name | Type | Description |
|---|---|---|
| Cefdinir 300 mg Capsule (Sandoz, Austria) | DRUG | - |
| Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) | DRUG | - |
| Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria) | DRUG | - |
| Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, 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.