An interaction study with digoxin and AZD1305
Study identifier:D3190C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A phase I, randomised, open, single-centre, three-period crossover study to evaluate the effect of AZD1305 on the pharmacokinetics of digoxin after repeated oral administration of AZD1305 and digoxin to young healthy male volunteers
Medical condition
Atrial Fibrillation
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1305, Digoxin
Sex
Male
Actual Enrollment
18
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Aug 2008
Primary Completion Date: 01 Nov 2008
Study Completion Date: 01 Nov 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD1305 tablet | Drug: AZD1305 Extended Release tablet, repeated administration |
| Experimental: 2 AZD1305 tablet + digoxin | Drug: AZD1305 Extended Release tablet, repeated administration Drug: Digoxin Tablet, repeated administration |
| Active Comparator: 3 Digoxin | Drug: Digoxin Tablet, repeated administration |
Contacts
Investigators
Principal Investigator
Helen Lunde
AstraZeneca R&D Mölndal, Sweden
