An interaction study of ketoconazole/verapamil versus AZD1305
Study identifier:D3190C00009
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A phase I, single-centre, randomised, open, three-way crossover study to evaluate the effect of ketoconazole and verapamil, respectively, on the pharmacokinetics of AZD1305 after repeated oral adm of ketoconazole and verapamil and single oral dosing of AZD1305 to young healthy male volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Ketoconazole, Verapamil, AZD1305
Sex
Male
Actual Enrollment
27
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jul 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 Ketoconazole tablet + AZD1305 Extended Release tablet | Drug: Ketoconazole Tablet, administered as repeated doses. Other Name: Fungoral Drug: AZD1305 Extended Release tablet, administered as a single dose. |
| Experimental: 2 Verapamil Extended Release tablet + AZD1305 Extended Release tablet | Drug: Verapamil Extended Release tablet, administered as repeated doses. Other Name: Isoptin Retard Drug: AZD1305 Extended Release tablet, administered as a single dose. |
| Experimental: 3 AZD1305 Extended Release tablet | Drug: AZD1305 Extended Release tablet, administered as a single dose. |
Contacts
Investigators
Principal Investigator
Helen Lunde
AstraZeneca R&D Mölndal, Sweden
