A Drug-Drug Interaction study between AZD1981 and Pravastatin to study the effect of AZD1981 on the kinetics of pravastatin
Study identifier:D9830C00016
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-023876-14
CTIS identifier:N/A
Study Complete
Official Title
A phase I, open label, randomised, parallel group study of repeated oral doses of AZD1981 (100 mg twice daily and 400 mg twice daily via tablet) for eight days and single doses of pravastatin (Pravachol® tablet 40 mg) to evaluate the pharmacokinetic interaction of AZD1981 and pravastatin in healthy male volunteers
Medical condition
Drug interaction
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1981, pravastatin
Sex
Male
Actual Enrollment
30
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Feb 2011
Primary Completion Date: 01 Apr 2011
Study Completion Date: 01 Apr 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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: A | Drug: AZD1981 100 mg per oral, twice daily for 8 days Drug: pravastatin 40 mg, once daily at Day 1, period A and Day 8, period B Other Name: pravachol |
| Experimental: B | Drug: AZD1981 4x100 mg per oral, twice daily for 8 days Drug: pravastatin 40 mg, once daily at Day 1, period A and Day 8, period B Other Name: pravachol |
