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
18 Years
N/A
Both
Pharmacokinetics
Trial Information
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
Inclusion Criteria:
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 Criteria:
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum
Outcome Time Frame:
predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A0661145
NCT ID:
NCT00644176
Start Date:
November 2004
Completion Date:
April 2005
Related Keywords:
- Pharmacokinetics
Name | Location |
|---|
