Investigate the effect of AZD1656 on the pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
Study identifier:D1020C00031
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 of Digoxin During Co-administration with AZD1656
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1656, Digoxin, Placebo
Sex
All
Actual Enrollment
20
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Dec 2010
Study Completion Date: 01 Dec 2010
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 twice daily Day 1 to Day 7; digoxin on day 4 | Drug: AZD1656 Oral tablet bd, step-wise increased dosage Drug: Digoxin Oral tablet od on Day 4 Other Name: Digacin |
| Placebo Comparator: 2 twice daily Day 1 to Day 7; digoxin on day 4. | Drug: Digoxin Oral tablet od on Day 4 Other Name: Digacin Drug: Placebo Oral tablet bd, step-wise increased dosage |
Contacts
Investigators
Principal Investigator
Stanko Skrtic
AstraZeneca
