A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects
This study has been completed.
Sponsor:
Pharmaxis
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00446771
First received: March 12, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Mannitol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Pharmaxis:
Primary Outcome Measures:
- 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 Outcome Measures:
- A secondary objective of the study is to provide information on the urinary excretion of mannitol after each of the routes of administration.
| Estimated Enrollment: | 18 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | November 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00446771 History of Changes |
| Other Study ID Numbers: | DPM-PK-101 |
| Study First Received: | March 12, 2007 |
| Last Updated: | March 12, 2007 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Mannitol Diuretics, Osmotic Diuretics Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013