Status:
COMPLETED
Safety and Blood Level Study of Unit Dose Budesonide
Lead Sponsor:
Allergan
Collaborating Sponsors:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Q-Pharm Pty Limited
Conditions:
Asthma
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- Any use of corticosteroid in previous 4 weeks
- Pregnancy/lactation
- Significant blood donation (or testing) in previous 8 weeks
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00627679
Start Date
December 1 2005
End Date
May 1 2006
Last Update
January 9 2014
Active Locations (1)
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1
Q-Pharm Pty Limited
Brisbane, Queensland, Australia, QLD 4006