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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00446771
First Posted: March 13, 2007
Last Update Posted: March 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharmaxis
  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
Intervention Model: Crossover Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446771


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

ClinicalTrials.gov Identifier: NCT00446771     History of Changes
Other Study ID Numbers: DPM-PK-101
First Submitted: March 12, 2007
First Posted: March 13, 2007
Last Update Posted: March 13, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs