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

Syntara

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Mannitol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00446771

DPM-PK-101

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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