A Pharmacokinetic and Bioavailability Study of Mannitol f... | NCT00446771

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

NCT00446771

Sponsor

Syntara

Status

Completed

Last Update Posted

Mar 13, 2007Estimated

Enrollment

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Mannitol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006

First Submitted Date

Mar 12, 2007

First Submission Date that Met QC Criteria

Mar 12, 2007

First Posted Date

Mar 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2007

Last Update Posted Date

Mar 13, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Mannitol	Drug

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates