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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
66
azithromycin IR 500 mg tablet by mouth for 1 dose
placebo
2.0 g by mouth in the form of liquid for 1 dose
placebo
Pfizer Investigational Site
Pisa, Italy
Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum
Time frame: predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples
Time frame: 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
12-lead electrocardiograms (ECGs)
Time frame: Screening and 72 hours postdose
adverse events (AEs)
Time frame: Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
safety laboratory tests
Time frame: Treatment day 0 and 72 hours postdose
vital signs
Time frame: Screening and Treatment day 0
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