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

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ClinicalTrials.gov Identifier: NCT00627679
Recruitment Status : Completed
First Posted : March 3, 2008
Results First Posted : October 23, 2013
Last Update Posted : January 9, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Budesonide Inhalation Suspension Drug: MAP0010 low dose Drug: MAP0010 intermediate dose Drug: MAP0010 high dose Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : December 2005
Primary Completion Date : December 2005
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources

Arms and Interventions

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 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.


Outcome Measures

Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00627679     History of Changes
Other Study ID Numbers: MAP0010-CL-P101
First Posted: March 3, 2008    Key Record Dates
Results First Posted: October 23, 2013
Last Update Posted: January 9, 2014
Last Verified: December 2013

Keywords provided by Allergan:
Pediatric asthma

Additional relevant MeSH terms:
Budesonide
Anti-Inflammatory Agents
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