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
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics
Intervention: azithromycin immediate release (Zithromax) (Drug); placebo (Other); azithromycin SR (Drug); placebo (Other)
Phase: Phase 2
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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 liquid formulation (AZ-SR) in lung tissue and bronchial washings, the
latter consisting of the epithelial lining fluid (ELF) and cellular elements, mainly
alveolar macrophages (AM).
Official title: A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin in Serum, Bronchial Washings and Lung Tissue Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Resection
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum
Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples
12-lead electrocardiograms (ECGs)
adverse events (AEs)
safety laboratory tests
Minimum age: 18 Years.
Maximum age: N/A.
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.
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.
Locations and Contacts
Pfizer Investigational Site, Pisa 56126, Italy
To obtain contact information for a study center near you, click here.
Starting date: November 2004
Last updated: June 3, 2011