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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Mannitol

• Study Type: Interventional
• Enrollment: 18
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pharmaxis
• Investigators: Principal Investigator: Andrew Humberstone, Nucleus Networks

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion: December 7, 2022
• Study Completion: November 1, 2006

Study Registration Dates

• First Submitted: March 12, 2007
• First Submitted That Met QC Criteria: March 12, 2007
• First Posted (Estimate): March 13, 2007

Study Record Updates

• Last Update Posted (Estimate): March 13, 2007
• Last Update Submitted That Met QC Criteria: March 12, 2007
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: DPM-PK-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No