To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)
- Registration Number
- NCT00882570
- Lead Sponsor
- Sandoz
- Brief Summary
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting 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.
Exclusion Criteria
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria) Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria) 2 Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA) Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 10 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Cefdinir absorption in fasting conditions as studied in NCT00882570?
How does Cefdinir compare to Omnicef in terms of bioavailability and efficacy in healthy volunteers?
Are there specific biomarkers that influence the bioequivalence outcomes of Cefdinir formulations?
What adverse events are associated with Cefdinir oral suspension in phase 1 trials and how are they managed?
How does the bioequivalence of Cefdinir in NCT00882570 relate to its use in treating respiratory tract infections?