To evaluate the effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656
Study identifier:D1020C00030
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Open, Placebo controlled, Two-way Crossover Phase I Study in Type 2 Diabetes Mellitus Patients Treated with Metformin to Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1656, Gemfibrozil, Placebo
Sex
All
Actual Enrollment
19
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Mar 2010
Primary Completion Date: 01 Jun 2010
Study Completion Date: 01 Jun 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 Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4 | Drug: AZD1656 Single dose,oral tablet Drug: Gemfibrozil Oral tablet bid on day 1 – 5. Drug: Placebo Oral tablet bid on day 1-5 |
| Experimental: 2 Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4 | Drug: AZD1656 Single dose,oral tablet Drug: Gemfibrozil Oral tablet bid on day 1 – 5. Drug: Placebo Oral tablet bid on day 1-5 |
Contacts
Investigators
Principal Investigator
Stanko Skrtic
AstraZeneca
