A study in healthy subjects to investigate Pharmacokinetics of AZD8683 when administered in different ways
Study identifier:D1883C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase I, Single-centre, Open-label, Partly Randomised, Cross-over Single Dose Study in Healthy Volunteers to Evaluate the Absolute Pulmonary Bioavailability of AZD8683 when Administered Inhaled via a New Dry Powder Inhaler and via Turbuhaler™
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD8683
Sex
All
Actual Enrollment
0
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Nov 2012
Estimated Primary Completion Date: 01 Mar 2013
Estimated Study Completion Date: 01 Mar 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Dec 2012 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD8683 iv | Drug: AZD8683 Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683 |
| Experimental: 2 AZD8683 oral | Drug: AZD8683 Solution to be administered orally Total dose of 950 µg AZD8683 |
| Experimental: 3 AZD8683 inhalation New Dry Powder Inhaler | Drug: AZD8683 Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683 |
| Experimental: 4 AZD8683 inhalation Turbuhaler™ | Drug: AZD8683 Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683 |
Contacts
Investigators
Principal Investigator
Carin Jorup
AstraZeneca R&D, Molndal
Sweden
