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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Alabaster | Alabama | 35007 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | Miami | Florida | 33136-1002 | United States |
| Pfizer Investigational Site | Augusta | Georgia | 30912 | United States |
| Pfizer Investigational Site | Elgin | Illinois | 60120 | United States |
| Pfizer Investigational Site | Elgin | Illinois | 60123 | United States |
| Pfizer Investigational Site | Maywood | Illinois | 60153 | 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 |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D001800 | Blood Specimen Collection |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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