Status:
COMPLETED
A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Surgery
Lead Sponsor:
Pfizer
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this trial was to characterize the pharmacokinetics of the currently marketed azithromycin immediate release tablet formulation (AZ-IR) versus the azithromycin sustained release liqui...
Eligibility Criteria
Inclusion
- Inclusion criteria were hospitalized subjects diagnosed with lung cancer that had consented to surgery requiring lung resection who had a life expectancy of \>6 months.
Exclusion
- Key exclusion criteria were antibiotic prophylaxis prior to surgery, diffuse, non-infectious lung disease, history of cigarette smoking of \>5 packs per year, patients with any infectious disease that required antibiotic therapy, administration of drugs known to interfere with azithromycin pharmacokinetics, and subjects on chemotherapy.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00644176
Start Date
November 1 2004
End Date
April 1 2005
Last Update
June 8 2011
Active Locations (1)
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1
Pfizer Investigational Site
Pisa, Italy, 56126