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 2CompletedNCT00232154

Pfizer72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Sinusitis

Interventions

Zithromax (azithromycin) 500mg tabletsDRUG

Endoscopic Sinus SurgeryPROCEDURE

Blood sampling for hematologyPROCEDURE

Blood sampling for plasma chemistry profile

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (18)

Pfizer Investigational Site

Alabaster, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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