To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)Drug: Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
- Registration Number
- NCT00883883
- Lead Sponsor
- Sandoz
- Brief Summary
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
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Exclusion Criteria
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA) Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA) 1 Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria) Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 15 days
- Secondary Outcome Measures
Name Time Method