Status:
TERMINATED
Intrapulmonary Pharmacokinetics of Antibiotics
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Sanofi
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief 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 teli...
Eligibility Criteria
Inclusion
- Between 18 and 55 years, inclusive, of age
- No history of smoking within the last 1 year
- Body weight within +/- 15% of the Metropolitan Life Insurance Company tables
- No clinically important abnormalities in the medical history or physical exam
- Female subjects of childbearing potential must have a negative pregnancy test
- Female subjects of childbearing potential must use reliable methods of birth control
Exclusion
- Allergy to telithromycin, azithromycin, or any macrolide antibiotic
- Allergy or serious adverse reactions to benzodiazepines or lidocaine
- History of renal, gastrointestinal, or liver disease
- Significant hypertension
- Clinically significant heart or pulmonary diseases
- History of drug or alcohol dependence within 12 months of study entry
- Positive pregnancy test
- Currently breast feeding
- Use of any drug within 2 weeks of study entry
- Received an investigational drug within 30 days of study entry
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00315601
Start Date
January 1 2006
End Date
November 1 2006
Last Update
February 13 2009
Active Locations (1)
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1
Pulmonary Associates PA
Phoenix, Arizona, United States, 85006