Safety and Blood Level Study of Unit Dose Budesonide (UDB P101)

This study has been completed.

Sponsor:

Collaborator:

Q-Pharm Pty Limited

Information provided by:

MAP Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00627679

First received: February 22, 2008

Last updated: January 23, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2008

Last Updated Date

January 23, 2009

Start Date ^ICMJE

December 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Tolerability of new nebulized formulation of budesonide [ Time Frame: 8 hours after each of 4 doses ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00627679 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics of budesonide after 3 doses of MAP0010 and 1 of a commercial budesonide formulation all delivered through the same nebulizer system on different days. [ Time Frame: 8 hours after each of 4 doses ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Blood Level Study of Unit Dose Budesonide

Official Title ^ICMJE

A Randomized, Double Blind, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of MAP0010

Brief Summary

The purpose of this study is to study how well three doses of a new formulation of budesonide (for the treatment of asthma) are tolerated by healthy adults compared to a currently approved and marketed formulation, and to examine blood levels of budesonide after the four different doses in each volunteer.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Budesonide

Single dose by nebulization

Other Names:

Unit Dose Budesonide
Pulmicort Respules (0.25mg/2mL)

Study Arm (s)

Experimental: 1
MAP0010 - high dose

Intervention: Drug: Budesonide
Experimental: 2
MAP0010 - intermediate dose

Intervention: Drug: Budesonide
Experimental: 3
MAP0010 - low dose

Intervention: Drug: Budesonide
Active Comparator: 4
Budesonide Inhalation Suspension (0.25mg/2mL)

Intervention: Drug: Budesonide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2006

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy adult volunteers, aged 18-50 years
BMI less than 30 kg/m2
Non smoker (currently and <10 pack years total if ex-smoker)

Exclusion Criteria:

Any use of corticosteroid in previous 4 weeks
Pregnancy/lactation
Significant blood donation (or testing) in previous 8 weeks

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00627679

Other Study ID Numbers ^ICMJE

MAP0010-CL-P101

Has Data Monitoring Committee

Responsible Party

Alan Cohen, VP Clinical Development and Medical Affairs, MAP Pharmaceuticals Inc

Study Sponsor ^ICMJE

MAP Pharmaceuticals, Inc.

Collaborators ^ICMJE

Q-Pharm Pty Limited

Investigators ^ICMJE

Principal Investigator:

Joanne Marjason, MBBS

Q-Pharm Pty Limited

Information Provided By

MAP Pharmaceuticals, Inc.

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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