An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects
NCT ID: NCT00879983
Last Updated: 2010-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2009-05-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Group 1
Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet.
azithromycin (Zithromax)
1. a single dose of azithromycin ER 2g
2. 3-day regimen of azithromycin tablet 500mg
Group 2
Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER .
azithromycin (Zithromax)
1. 3-day regimen of azithromycin tablet 500mg
2. a single dose of azithromycin ER 2g
Interventions
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azithromycin (Zithromax)
1. a single dose of azithromycin ER 2g
2. 3-day regimen of azithromycin tablet 500mg
azithromycin (Zithromax)
1. 3-day regimen of azithromycin tablet 500mg
2. a single dose of azithromycin ER 2g
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male.
* 18-45 years old.
* BMI 17.5-30.5 kg/m2.
Exclusion Criteria
* Sensitive to macrolide antibiotics class drug, parn or heparin-induced thrombocytopenia.
* Severe medical or psychiatric condition or laboratory abnormality.
* Blood donation.
* 12-ECG abnormal.
* Treatment with study drug; clinically significant.
18 Years
45 Years
MALE
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Shanghai, , China
Countries
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Related Links
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Other Identifiers
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A0661179
Identifier Type: -
Identifier Source: org_study_id
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