Pharmacodynamics(PD) study of Arbekacin Sulfate in Epithelial Lining Fluid (ELF), an open-label study.

Pharmacodynamics(PD) study of Arbekacin Sulfate in Epithelial Lining Fluid (ELF), an open-label study. - PD study of Arbekacin Sulfate in ELF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007162

Enrollment

Registered

2012-01-31

Start date

2011-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteer

Interventions

intravenous drip of arbekacin sulfate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers except exclusion criteria and abnormalities proved by the pre-medical test. With informed consent as volunteers.

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity caused by aminoglycoside antibiotics or bacitracin. 2) One who has family or patient's history of hearing loss caused by aminoglycoside antibiotics. One who has hearing loss caused by any other reasons. 3)In medication. 4)Creatinine clearance and less than 30mL/min. 5)Smorker. 6)Any other participants whose condition is inappropriate for the evaluation of this clinical study, judged by the investigator.

Design outcomes

Primary

Measure	Time frame
To evaluate PK in plasma and ELF of Arbekacin Sulfate, the ratio ELF:plasma of Arbekacin Sulfate.	—

Countries

Japan

Contacts

Public ContactYohei Funatsu

Keio University Hospital Division of Pulmonary Medicine, Department of Medicine

dodeko81@ybb.ne.jp03-5363-3793

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026