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ClinicalTrials.gov Identifier: NCT00315601
Recruitment Status :
(Sanofi-Aventis wanted the study terminated.)
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.
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Allergy to telithromycin, azithromycin, or any macrolide antibiotic
Allergy or serious adverse reactions to benzodiazepines or lidocaine
History of renal, gastrointestinal, or liver disease
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