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

Phase 2

Completed

• Conditions: Sinusitis

• Registration Number: NCT00232154
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-04
• Study Start: 2005-11
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-20
• Last Update Posted: 2011-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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).

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Exclusion Criteria

• Known or suspected hypersensitivity or intolerance to any macrolide-like compound, including erythromycin, clarithromycin, azithromycin or telithromycin.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States