A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects (NCT00446771)

Study 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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Syntara is the lead sponsor of 31 studies on the registry; none are open to participants now.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: Yes

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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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 18 participants

Interventions

DrugMannitol

What researchers measure

Primary outcomes

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 outcomes

A secondary objective of the study is to provide information on the urinary excretion of mannitol after each of the routes of administration.

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00446771
Lead sponsor: Syntara
First posted: Mar 13, 2007
Start date: Oct 2006
Completion: Nov 2006
Last update: Mar 13, 2007

Study contacts

Andrew Humberstone

principal investigator · Nucleus Networks

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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