Safety and Blood Level Study of Unit Dose Budesonide
Information source: MAP Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Budesonide (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: MAP Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
Joanne Marjason, MBBS, Principal Investigator, Affiliation: Q-Pharm Pty Limited
Summary
The purpose of this study is to study how well three doses of a new formulation of budesonide
(for the treatment of asthma) are tolerated by healthy adults compared to a currently
approved and marketed formulation, and to examine blood levels of budesonide after the four
different doses in each volunteer.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Tolerability of new nebulized formulation of budesonide
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Q-Pharm Pty Limited, Brisbane, Queensland QLD 4006, Australia
Additional Information
Starting date: December 2005
Ending date: May 2006
Last updated: February 29, 2008
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