Study identifier:D2340C00012
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system
Bioavailability and AUC
Phase 1
Yes
AZD5423
Male
18
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Jan 2015 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 AZD5423 iv | Drug: AZD5423 solution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423 |
Experimental: 2 AZD5423 inhalation, Spira | Drug: AZD5423 nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423 |
Experimental: 3 AZD5423 inhalation I-neb | Drug: AZD5423 nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423 |
Experimental: 4 AZD5423 oral | Drug: AZD5423 nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423 |
Experimental: 5 AZD5423 inhalation Turbuhaler | Drug: AZD5423 dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423 |
Experimental: 6 AZD5423, New Dry Powder Inhaler | Drug: AZD5423 dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423 |