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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

February 22, 2008
December 9, 2013
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 ] [ 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).
Tolerability of new nebulized formulation of budesonide [ Time Frame: 8 hours after each of 4 doses ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00627679
MAP0010-CL-P101
No
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