Investigation on bronchoalveolar lavage technique as an evaluation of drug migration to lung tissue
- Conditions
- Respiratory Disease
- Registration Number
- JPRN-UMIN000012895
- Lead Sponsor
- Medical Co. LTA Clinical Pharmacology Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 6
Not provided
1, Subject who has allergy or had hypersensitivity to lidocaine and/or azithromycin hydrate. And/or subject with illness which prohibits administration of these substances. 2, Subject with history of drug allergy. 3, Subject who received medical treatment 2 months prior to BAL. 4, Subject who donated more than 400ml or 200ml of blood within 3 months or 1 month prior to BAL, respectively. 5, Subject whose result of screening examinations (include vital sign, 12-lead ECG, and safety laboratory tests) deviates from reference range, and the deviation is judged clinically significant by study physician. 6, Subject who takes drug habitually and/or who abuses alcoholic beverage. 7, Subject who acquired severe medical illness within 4 months prior to BAL. 8, Subject with positive test results of syphilis, HIV antigen/antibody, HBs antigen, and/or HCV antibody. Or subject with sign of infection. 9, Subject who smokes within 6 months prior to BAL. 10, Subject who are considered to be inadequate for this study by study physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method