Study identifier:D4711C00002
ClinicalTrials.gov identifier:NCT02178059
EudraCT identifier:N/A
CTIS identifier:N/A
An Open-label, Single-dose, 2-period Cross over Study in Healthy Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg after Inhalation via the M3 Turbuhaler Compared with the M2 Turbuhaler
Healthy Volunteers
Phase 1
Yes
terbutaline sulphate delivered dose, terbutaline sulphate metered dose
All
34
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Jan 2017 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Bricanyl Turbuhaler M3 0.4 mg terbutaline sulphate (delivered dose) per inhalation | Drug: terbutaline sulphate delivered dose 0.4 mg terbutaline sulphate (delivered dose) per inhalation Other Name: Turbuhaler New Version |
Active Comparator: Bricanyl Turbuhaler M2 0.5 mg terbutaline sulphate (metered dose) per inhalation | Drug: terbutaline sulphate metered dose 0.5 mg terbutaline sulphate (metered dose) per inhalation Other Name: Turbuhaler Current Version |