NCT00315601

Intrapulmonary Pharmacokinetics of Antibiotics

Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The major objectives of this research are to see how much, and for how long, telithromycin and azithromycin get into the fluids and cells of the lung.

Detailed description

The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM) concentrations following multiple oral doses of telithromycin and azithromycin in healthy, non-smoking adult subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Telithromycin	800 mg once a day for 5 days
DRUG	azithromycin	500 mg on day 1, and then 250 mg once-daily on days 2 through 5
PROCEDURE	bronchoalveolar lavage	One bronchoscopy with bronchoalveolar lavage with each drug administration
DRUG	Telithromycin	Telithromycin 800 mg once a day

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2006-04-18
• Last updated: 2009-02-13

Locations

1 site across 1 country: United States