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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

Primary outcomes

To determine the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously.
To determine the relative bioavailability of mannitol powder for inhalation by comparison to orally administered mannitol.
To determine the pharmacokinetic parameters of systemically available mannitol after administration of mannitol powder by inhalation.

Secondary outcomes

A secondary objective of the study is to provide information on the urinary excretion of mannitol after each of the routes of administration.

Sponsors and collaborators

Lead sponsor

Syntara

Industry

Registry information

Important dates

Study start: 2006
Study completion: 2006
First posted: Mar 13, 2007
Registry last updated: Mar 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed