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OpenTrials
Completed

NCT Number: NCT00232154

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

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.

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Alabaster, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 4, 2005
Registry last updated
Apr 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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