Lung Deposition Via Different Inhalation Devices
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Pulmicort pMDI HFA (Drug); Budesonide pMDI HFA (Drug); Pulmicort Repulses (Drug); Pulmicort Turbohaler (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Carin Jorup, Study Director, Affiliation: AstraZeneca R&D Lund, Sweden
Pia Lena Berg, Principal Investigator, Affiliation: Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Summary
The purpose of this study is to assess the deposition of budesonide to the lung after
inhalation with 5 different devices and to relate the findings to in vitro properties of
inhaled budesonide.
Clinical Details
Official title: A Phase I, Randomized, Open-label, 5-way Crossover, Single Centre Study in Healthy Subjects to Assess the Lung Deposition of Inhaled Budesonide Delivered Via Different Inhalation Devices
Study design: Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Lung deposition of budesonide (AUC)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- BMI between 18 and 30 kg/m2
- Non-smokers/non-snuffers
Exclusion Criteria:
- Pregnant and/or lactating women
- Use of oral contraceptives or hormonal implants
- Known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or
other excipients in study drugs
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Lund, Sweden; Recruiting
Additional Information
Starting date: September 2009
Ending date: November 2009
Last updated: September 23, 2009
|
