drugset / Trial / NCT01907776
Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to determine the systemic exposure to, and urinary elimination of, ME1100.
Timeline
- Start
- 2013-07
- Primary completion
- 2013-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arbekacin | Unknown | 0.6 ml | Inhaled |
| Subject | Arbekacin | Unknown | 2 ml | Inhaled |
| Subject | Arbekacin | Unknown | 3 ml | Inhaled |
| Subject | Arbekacin | Unknown | 4 ml | Inhaled |
| Subject | Arbekacin | Unknown | 6 ml | Inhaled |
| Subject | Arbekacin | Unknown | 9 ml | Inhaled |
Indications
No indication recorded.