Status:
COMPLETED
Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects
Lead Sponsor:
Keith A. Rodvold
Collaborating Sponsors:
Pulmonary Associates, PA
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is being performed to measure the amount of the antibiotic doripenem (study drug) found in the fluid and cells of the lung and blood after receiving three doses of doripenem. The major obje...
Detailed Description
The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) concentrations following multiple intravenous doses...
Eligibility Criteria
Inclusion
- Healthy men and women at least 18 years of age who have no history of smoking within the last 1 year.
- Subjects must be healthy with no clinically important abnormalities in the medical history, physical examination, or laboratory values.
Exclusion
- Subjects must not have a history of allergic or other serious reactions to doripenem or any beta-lactam antibiotic, benzodiazepines or lidocaine.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00925392
Start Date
June 1 2009
End Date
January 1 2010
Last Update
March 14 2013
Active Locations (1)
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1
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006