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The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH) |
|
| 2 | Active Comparator | Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH) | Drug |
| ||
| Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magdy L. Shenouda, M.D. | MDS Pharma Services | Principal Investigator |
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| Drug |
|
| ID | Term |
|---|---|
| D000097670 | Cefprozil |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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