Investigate the effect of AZD1656 on the pharmacokinetics and pharmacodynamics of Warfarin in type 2 diabetes mellitus (T2DM) patients
Study identifier:D1020C00027
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-Label, Randomised, Placebo-Controlled, Two-Way Crossover, Phase I Single Centre Study in Type 2 Diabetes Mellitus Patients Treated with Metformin to Evaluate the Pharmacokinetics and Pharmacodynamics of Warfarin During Co-administration with AZD1656
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
No
Study drug
Warfarin, Placebo, AZD1656
Sex
All
Actual Enrollment
16
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Apr 2010
Primary Completion Date: 01 Aug 2010
Study Completion Date: 01 Aug 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics 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 twice daily on Day 1 to Day 10, with Warfarin on Day 4 | Drug: Warfarin Oral tablet od on Day 4 Drug: AZD1656 Oral tablet bd, stepwise increased |
| Placebo Comparator: 2 twice daily on Day 1 to Day 10, with Warfarin on Day 4 | Drug: Warfarin Oral tablet od on Day 4 Drug: Placebo Oral tablet bd, stepwise increased |
Contacts
Investigators
Principal Investigator
Stanko Skrtic
AstraZeneca
