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

December 9, 2013 updated by: Allergan

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

The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, QLD 4006
        • Q-Pharm Pty Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment sequence: A, B, D, C
Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5
Drug: Budesonide Inhalation Suspension
Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Other Names:
  • Pulmicort Respules®
Drug: MAP0010 low dose
Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Drug: MAP0010 intermediate dose
Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Drug: MAP0010 high dose
Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Experimental: Treatment sequence: B, C, A, D
Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
Drug: Budesonide Inhalation Suspension
Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Other Names:
  • Pulmicort Respules®
Drug: MAP0010 low dose
Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Drug: MAP0010 intermediate dose
Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Drug: MAP0010 high dose
Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Experimental: Treatment sequence: C, D, B, A
Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 5
Drug: Budesonide Inhalation Suspension
Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Other Names:
  • Pulmicort Respules®
Drug: MAP0010 low dose
Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Drug: MAP0010 intermediate dose
Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Drug: MAP0010 high dose
Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Experimental: Treatment sequence: D, A, C, B
Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5
Drug: Budesonide Inhalation Suspension
Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Other Names:
  • Pulmicort Respules®
Drug: MAP0010 low dose
Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Drug: MAP0010 intermediate dose
Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Drug: MAP0010 high dose
Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010
Time Frame: 8 hours
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
8 hours
Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Time Frame: 8 hours
Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).
8 hours
AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010
Time Frame: 8 hours
The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml).
8 hours
AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Time Frame: 8 hours
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).
8 hours
Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Time Frame: 8 hours
Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Collaborators

MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Q-Pharm Pty Limited

Investigators

  • Principal Investigator: Joanne Marjason, MBBS, Q-Pharm Pty Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAP0010-CL-P101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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