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

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. Identifier: NCT00446771
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : March 13, 2007
Information provided by:

March 12, 2007
March 13, 2007
March 13, 2007
October 2006
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  • 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
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A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects
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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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Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteers
Drug: Mannitol
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2006
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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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Principal Investigator: Andrew Humberstone Nucleus Networks
March 2007

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