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

This study has been completed.
Sponsor:
Collaborators:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Q-Pharm Pty Limited
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00627679
First received: February 22, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Budesonide Inhalation Suspension
Drug: MAP0010 low dose
Drug: MAP0010 intermediate dose
Drug: MAP0010 high dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of MAP0010

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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).

  • Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).

  • AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010 [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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).

  • AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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).

  • Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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).


Enrollment: 16
Study Start Date: December 2005
Study Completion Date: May 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627679

Locations
Australia, Queensland
Q-Pharm Pty Limited
Brisbane, Queensland, Australia, QLD 4006
Sponsors and Collaborators
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Q-Pharm Pty Limited
Investigators
Principal Investigator: Joanne Marjason, MBBS Q-Pharm Pty Limited
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00627679     History of Changes
Other Study ID Numbers: MAP0010-CL-P101
Study First Received: February 22, 2008
Results First Received: August 19, 2013
Last Updated: December 9, 2013
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by Allergan:
Pediatric asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014