A single dose, 3-way cross-over study comparing the safety, tolerability and pharmacokinetics of two inhaled Liposomal Ciprofloxacin Hydrochloride (HCl) for Inhalation formulations in two different nebulizers in healthy adults, with single dose assessment in subjects with non-Cystic Fibrosis (CF) bronchiectasis.
A single dose, 3-way cross-over study comparing the safety, tolerability and pharmacokinetics of two inhaled Liposomal Ciprofloxacin Hydochloride (HCl) for Inhalation formulations in two different nebulizers in healthy adults, with single dose assessment in subjects with non-Cystic Fibrosis (CF) bronchiectasis.
Aradigm Corporation
15 participants
Mar 16, 2009
Interventional
Conditions
Summary
This research study aims to evaluate the safety and tolerability of two formulations of liposomal ciprofloxacin when inhaled using two diflerent nebulizers. It will also study the uptake and removal of ciprofloxacin from the human body. The sponsor wants to know which formulation/device combination is the most tolerable to test in patients with bronchiectasis, a rare disease that affects people's lungs. There are two parts to this study. The first part will include healthy adults and the second part will include patients with bronchiectasis.
Eligibility
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Interventions
Liposomal Ciprofloxacin Hydrochloride (HCL) for Inhalation is a dispersion developed for inhalation consisting of ciprofloxacin hydrochloride encapsulated in liposomes and formulated to contain 50 mg/ml of ciprofloxacin. The mixture formulation also referred to as MIXTURE contains equal volumes of this Liposomal Ciprofloxacin Hydrochloride (HCL) for Inhalation (50 mg/ml) [50%] and the Ciprofloxacin Hydrochloride (HCl) solution (24 mg/ml) for Inhalation [50%]. Formulations will be administered using an AKITA Jet nebulizer or an AKITA Apixneb.nebulizer Healthy subjects will receive Liposomal Ciprofloxacin HCL for Inhalation doses in the morning . The three doses are: A: Liposomal Ciprofloxacin Hydrochloride (HCl) for Inhalation (LC) plus normal saline using AKITA Jet nebulizer in healthy subjects. B: Liposomal Ciprofloxacin Hydrochloride (HCl) for Inhalation(LC) plus Ciprofloxacin Hydrochloride (HCl) Solution for Inhalation = MIXTURE by AKITA Jet nebulizer in healthy subjects C: MIXTURE - Liposomal Ciprofloxacin for Inhalation (LC) plus Ciprofloxacin Hydrochloride (HCl) Solution for Inhalation (FC, combined = MIXTURE) by the Apixneb nebulizer in healthy subjects. Doses will be randomly assigned to each subject, to be received in one of six different sequences The intervention administered as three separate formulation/device combinations. Each of the Liposomal Ciprofloxacin Hydrochloride (HCL) for Inhalation treatments will be separated by at least 5 days or 120 hours for ciprofloxacin to wash out of the body. Non-Cystic Fibrosis (CF) bronchiectasis patients will be screened and six subjects will be selected under separate inclusion and exclusion criteria from the healthy subjects. The single dose selected from the safety and tolerability results of the healthy subject cross-over dosing will be administered as a single dose to the 6 subjects with non-CF bronchiectasis. The reference dose,Tobramycin solution for inhalation(TOBI 'Registered Trademark'), will also be administered to the subjects with non-Cystic Fibrosis (CF) bronchiectasis. The selected dose will only be administered once. The same pre and post dose assessments for each dosing day will apply to the non-Cystic Fibrosis (CF)bronchiectasis population as the healthy subjects. There are 3 treatment days separated by at least 5 days or 120 hours for ciprofloxacin to wash out of the body. Subjects will report to the Phase I Unit the afternoon prior to the reference treatment day where they will recieve Reference formulation Tobramycin solution for inhalation (TOBI 'Registered Trademark') administration by inhalation
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ACTRN12609000544279