drugset / Trial / NCT01907776

Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers

NCT01907776 ↗

Phase 1 Completed 56 enrolled Meiji Seika Pharma Co., Ltd.
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

EvaluationDrugModalityDoseRoute
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.