Back to resultsComparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions
Primary Purpose
Infections
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC
Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer
Sponsored by
About this trial
This is an interventional treatment trial for Infections
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Azithromycin for oral suspension 200mg/5mL
Zithromax (azithromycin for oral suspension) 200mg/5mL
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00875966
Brief Title
Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Azithromycin for oral suspension 200mg/5mL
Arm Title
2
Arm Type
Active Comparator
Arm Description
Zithromax (azithromycin for oral suspension) 200mg/5mL
Intervention Type
Drug
Intervention Name(s)
Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC
Intervention Type
Drug
Intervention Name(s)
Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer
Intervention Description
Subjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
37 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions
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