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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo
Drug: Gemfibrozil
Drug: AZD1656

Study type

Interventional

Funder types

Industry

Identifiers

NCT01083212
D1020C00030

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

Enrollment

19 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

19 participants in 2 patient groups

1
Experimental group
Description:
Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4
Treatment:
Drug: Gemfibrozil
Drug: AZD1656
Drug: Placebo
2
Experimental group
Description:
Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4
Treatment:
Drug: Gemfibrozil
Drug: AZD1656
Drug: Placebo

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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