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Sponsored by: |
Sandoz Inc. |
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Information provided by: | Sandoz Inc. |
ClinicalTrials.gov Identifier: | NCT00882570 |
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria) Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment |
Official Title: | A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 250mg/5 ml Cefdinir (Test Formulation) and Omnicel 250mg/5 ml Powder For Oral Suspension (Reference Formulation) Each Given as a Single Oral Dose to Forty Healthy Male and/or Female Volunteers in the Fasting State |
Enrollment: | 40 |
Study Start Date: | April 2005 |
Study Completion Date: | May 2005 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)
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Drug: Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria) |
2: Active Comparator
Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)
|
Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA) |
Ages Eligible for Study: | 18 Years to 56 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sandoz Inc. ( Eric Mittleberg, Ph.D, VP of Product Development ) |
Study ID Numbers: | 50040 |
Study First Received: | April 15, 2009 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00882570 History of Changes |
Health Authority: | United States: Institutional Review Board |
Antibiotic |
Cephalosporins Anti-Bacterial Agents Cefdinir Cefixime Healthy |
Anti-Infective Agents Anti-Bacterial Agents Cephalosporins |
Therapeutic Uses Cefdinir Pharmacologic Actions |