NCT00875966CompletedPhase 1
Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sandoz
- Enrollment
- 42
- Primary Endpoint
- Bioequivalence based on AUC and Cmax
Study Overview
Brief Summary
The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •No clinically significant findings on physical exam, medial history or laboratory tests on screening
Exclusion Criteria
- •Positive test for HIV or hepatitis B and C
- •Treatment for Drug or alcohol abuse
- •Any other important criteria in the protocol
Arms & Interventions
2
Active Comparator
Zithromax (azithromycin for oral suspension) 200mg/5mL
Intervention: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer (Drug)
1
Experimental
Azithromycin for oral suspension 200mg/5mL
Intervention: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC (Drug)
Outcomes
Primary Outcomes
Bioequivalence based on AUC and Cmax
Time Frame: 37 days
Secondary Outcomes
No secondary outcomes reported
Investigators
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