Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions
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
1 other identifier
interventional
42
0 countries
N/A
Brief Summary
The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2004
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 3, 2009
CompletedFirst Posted
Study publicly available on registry
April 6, 2009
CompletedMarch 29, 2017
April 1, 2009
2 months
April 3, 2009
March 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Bioequivalence based on AUC and Cmax
37 days
Study Arms (2)
1
EXPERIMENTALAzithromycin for oral suspension 200mg/5mL
2
ACTIVE COMPARATORZithromax (azithromycin for oral suspension) 200mg/5mL
Interventions
Subjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions
Eligibility Criteria
You may qualify if:
- No clinically significant findings on physical exam, medial history or laboratory tests on screening
You may not qualify if:
- Positive test for HIV or hepatitis B and C
- Treatment for Drug or alcohol abuse
- Any other important criteria in the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 3, 2009
First Posted
April 6, 2009
Study Start
August 1, 2004
Primary Completion
October 1, 2004
Study Completion
October 1, 2004
Last Updated
March 29, 2017
Record last verified: 2009-04