Safety and Blood Level Study of Unit Dose Budesonide

Study Identifier
MAP0010-CL-P101
CT.gov Identifier
NCT00627679
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Asthma
    • Study Drug
  • Budesonide Inhalation Suspension
  • MAP0010 low dose
  • MAP0010 intermediate dose
  • MAP0010 high dose
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 50 Years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Q-Pharm Pty Limited
    Brisbane, Queensland, Australia, QLD 4006
    Status
    Not applicable