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 Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
- 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.
- A secondary objective of the study is to provide information on the urinary excretion of mannitol after each of the routes of administration.
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||November 2006|