A Drug-Drug Interaction Study to study the effect of AZD1981 on Warfarin
Study identifier:D9830C00017
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-021956-24
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) for Two Weeks and Single Doses of Warfarin (25 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Warfarin and the Effect of AZD1981 on Warfarin Pharmacodynamics in Healthy Male Volunteers
Medical condition
pharmakokinetic
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1981, Warfarin
Sex
Male
Actual Enrollment
28
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Oct 2010
Primary Completion Date: 01 Dec 2010
Study Completion Date: 01 Dec 2010
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: Treatment A AZD1981, low dose, + Warfarin | Drug: AZD1981 100 mg per oral, twice daily for 14 days Drug: Warfarin 10 x 2.5 mg per oral, once daily at day 1 and day 15 Other Name: Waran |
| Experimental: Treatment B AZD1981, high dose, + Warfarin | Drug: Warfarin 10 x 2.5 mg per oral, once daily at day 1 and day 15 Other Name: Waran Drug: AZD1981 4 x 100 mg per oral, twice daily for 14 days |
Contacts
Investigators
Principal Investigator
Christer Hultqvist
AstraZeneca
