A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects
|ClinicalTrials.gov Identifier: NCT00446771|
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : March 13, 2007
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Mannitol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2006|
|Estimated Study Completion Date :||November 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446771
|Principal Investigator:||Andrew Humberstone||Nucleus Networks|