Trial | NCT01083212  Report issue

Title

To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    19
The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656
Study Started
Mar 31
2010
Primary Completion
Jun 30
2010
Study Completion
Jun 30
2010
Last Update
Jul 01
2010
Estimate

Drug AZD1656

Single dose,oral tablet

Drug Gemfibrozil

Oral tablet bid on day 1 - 5.

Drug Placebo

Oral tablet bid on day 1-5

1 Experimental

Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4

2 Experimental

Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4

Criteria 

Inclusion Criteria:

Patients with confirmed Type 2 diabetes mellitus for at least 1 year and treated with metformin.
Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria:

Intake of another investigational drug within the last 30 days prior to enrolment.
Clinically significant illness or clinically relevant trauma.
No Results Posted