Inhalation of a dry powder ciprofloxacin formulation in healthy subjects: a phase I study.

ABSTRACT:

Background

Oral and intravenous formulations of ciprofloxacin have established efficacy and safety profiles in respiratory infections. A dry powder for inhalation (DPI) that uses Novartis' PulmoSphere™ technology has been developed to deliver high concentrations of ciprofloxacin to the lung with low systemic exposure using a portable and convenient passive dry powder inhaler (Novartis' T-326 inhaler).

Objectives

The primary objective was to investigate the safety and tolerability of ciprofloxacin DPI in healthy male subjects, with a secondary objective to investigate the pharmacokinetics of ciprofloxacin after ciprofloxacin DPI administration.

Methods

This was a phase I, single-dose, single-site, randomized, single-blind, placebo-controlled, crossover study conducted

SUBMITTER: Stass H 

PROVIDER: S-EPMC3664741 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature