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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

March 12, 2007
March 12, 2007
October 2006
Not Provided
  • 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.
Same as current
No Changes Posted
A secondary objective of the study is to provide information on the urinary excretion of mannitol after each of the routes of administration.
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects
Not Provided

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
Drug: Mannitol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2006
Not Provided

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00446771
DPM-PK-101
Not Provided
Not Provided
Pharmaxis
Not Provided
Principal Investigator: Andrew Humberstone Nucleus Networks
Pharmaxis
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP