Respiratory Disease
Conditions
Interventions
bronchoalveolar lavage
Sponsors
Medical Co. LTA Clinical Pharmacology Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1, Healthy Japanese male. 2, Subject between 20 and 45(inclusive) year of age. 3, Subject with weight <=40kg and >80kg, and with BMI <=18.5 and =>26.0 4, Subject with no abnormality observed by physician's examinations. 5, Subjects who receives screening examinations within one month prior to the study, and the results are judged as adequate for this study by study physician.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| amount and component of BALF, and cell count, erythrocyte count, and differential cell count in BALF | — |
Countries
Japan
Contacts
Public ContactMasanari Shiramoto
Medical Co. LTA Hakata Clinic Clinical Pharmacology Department
Outcome results
None listed