A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study has an open-label, randomized, crossover design, in which each subject will receive mannitol powder for inhalation using a dry powder inhaler with and without premedication with a bronchodilator, mannitol powder for inhalation in capsules administered orally, and mannitol in a commercial formulation designed for intravenous use.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmaxis
• Treatments: Mannitol

Criteria

Inclusion Criteria:

• Subject has signed a written informed consent form.

• Subject is a normal male volunteer between 18 and 65 years of age.

• Subject is willing to comply with the procedures of the study and to remain in the clinical unit for the scheduled visits.

• Subject is willing to abstain from chewing gum for the duration of the study.

Exclusion Criteria:

• Subject has asthma or other disease affecting the lungs or airways.

• Subject has a history indicating possible airway hyperresponsiveness.

• Subject is allergic to mannitol or gelatin or a known intolerance to intravenous mannitol.

• Subject uses inhaled drugs (legal or illegal).

• Subject uses oral bronchodilator drugs.

• Subject has celiac disease, Crohn's disease or other disease affecting intestinal absorption.

• Subject has renal impairment or other condition that would affect urine collection.

• Subject's weight deviates by more than 15% from the ideal weight listed for his height in the Metropolitan Life table.

• Subject is a smoker.

• Subject has participated in another clinical trial within the past 30 days.

• Subject has used chewing gum within the past 72 hours.

• Subject needs to use bisphosphonates, non-steroidal anti-inflammatory agents, or other drugs known to affect intestinal permeability on a chronic basis.

• Subject has used non-steroidal anti-inflammatory agents within the past 72 hours