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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00627679
First Posted: March 3, 2008
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Q-Pharm Pty Limited
Information provided by (Responsible Party):
Allergan
February 22, 2008
March 3, 2008
August 19, 2013
October 23, 2013
January 9, 2014
December 2005
December 2005   (Final data collection date for primary outcome measure)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Tolerability of new nebulized formulation of budesonide [ Time Frame: 8 hours after each of 4 doses ]
Complete list of historical versions of study NCT00627679 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Safety and Blood Level Study of Unit Dose Budesonide
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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: 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
    Interventions:
    • Drug: Budesonide Inhalation Suspension
    • Drug: MAP0010 low dose
    • Drug: MAP0010 intermediate dose
    • Drug: MAP0010 high dose
  • 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
    Interventions:
    • Drug: Budesonide Inhalation Suspension
    • Drug: MAP0010 low dose
    • Drug: MAP0010 intermediate dose
    • Drug: MAP0010 high dose
  • 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
    Interventions:
    • Drug: Budesonide Inhalation Suspension
    • Drug: MAP0010 low dose
    • Drug: MAP0010 intermediate dose
    • Drug: MAP0010 high dose
  • 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
    Interventions:
    • Drug: Budesonide Inhalation Suspension
    • Drug: MAP0010 low dose
    • Drug: MAP0010 intermediate dose
    • Drug: MAP0010 high dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2006
December 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00627679
MAP0010-CL-P101
No
Not Provided
Not Provided
Allergan
Allergan
  • MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
  • Q-Pharm Pty Limited
Principal Investigator: Joanne Marjason, MBBS Q-Pharm Pty Limited
Allergan
December 2013

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