Healthy Volunteers
Conditions
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 bronchodilator, mannitol powder for inhalation in capsules administered orally, and mannitol in a commercial formulation designed for intravenous use.
Interventions
DRUGMannitol
Sponsors
Syntara
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary objective of the study is to provide information on the urinary excretion of mannitol after each of the routes of administration. | — |
Outcome results
None listed