Clinical Drug Experience Knowledgebase

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