Status:
COMPLETED
A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects
Lead Sponsor:
Syntara
Conditions:
Healthy Volunteers
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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 bronchodil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00446771
Start Date
October 1 2006
End Date
November 1 2006
Last Update
March 13 2007
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