A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up To
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis
Intervention: Zithromax™ (azithromycin) 500mg tablets (Drug); Endoscopic Sinus Surgery (Procedure); Blood sampling for hematology (Procedure); Blood sampling for plasma chemistry profile (Procedure); Serum pregnancy test (for women of child-bearing potential) (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg
tablets for up to 3 days.
Clinical Details
Official title: An Open-Label Study Of Azithromycin Pharmacokinetics In Sinus Mucosal Tissue And Plasma In Subjects With Chronic Rhinosinusitis Following A Single 2g Dose Of Azithromycin Extended Release For Oral Suspension Or Azithromycin 500mg Tablet Formulation Once Daily For A Maximum Of Three Days
Study design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: To characterize the pharmacokinetics of azithromycin in sinus mucosal tissue and plasma in adult subjects after treatment with a single 2 g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500 mg tablet
Secondary outcome: To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects considered by the Principal Investigator as an appropriate candidate for
endoscopic sinus surgery, e. g., for the removal of the thickened and diseased mucosal
tissue that blocks the ostiomeatal complex (OMC).
Exclusion Criteria:
- Known or suspected hypersensitivity or intolerance to any macrolide-like compound,
including erythromycin, clarithromycin, azithromycin or telithromycin.
Locations and Contacts
Pfizer Investigational Site, Alabaster, Alabama 35007, United States
Pfizer Investigational Site, Birmingham, Alabama 35209, United States
Pfizer Investigational Site, Birmingham, Alabama 35233, United States
Pfizer Investigational Site, Birmingham, Alabama 35242, United States
Pfizer Investigational Site, Hoover, Alabama 35216, United States
Pfizer Investigational Site, Hoover, Alabama 35244, United States
Pfizer Investigational Site, Fresno, California 93720, United States
Pfizer Investigational Site, Miami, Florida 33136-1002, United States
Pfizer Investigational Site, Jacksonville, Florida 32216, United States
Pfizer Investigational Site, Augusta, Georgia 30912, United States
Pfizer Investigational Site, Maywood, Illinois 60153, United States
Pfizer Investigational Site, Elgin, Illinois 60120, United States
Pfizer Investigational Site, Elgin, Illinois 60123, United States
Pfizer Investigational Site, Carrollton, Kentucky 41008, United States
Pfizer Investigational Site, La Grange, Kentucky 40031, United States
Pfizer Investigational Site, Louisville, Kentucky 40207, United States
Pfizer Investigational Site, Durham, North Carolina 27710, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania 19104, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2005
Ending date: June 2006
Last updated: January 31, 2008
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