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

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00446771
First received: March 12, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Mannitol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

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

Estimated Enrollment: 18
Study Start Date: October 2006
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446771

Sponsors and Collaborators
Pharmaxis
Investigators
Principal Investigator: Andrew Humberstone Nucleus Networks
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00446771     History of Changes
Other Study ID Numbers: DPM-PK-101
Study First Received: March 12, 2007
Last Updated: March 12, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014