Investigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes Mellitus
- Registration Number
- NCT01082120
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine whether administration of AZD1656 will affect the pharmacokinetics of Pioglitazone and vice versa in patients with Type 2 Diabetes Mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Patients with confirmed Type 2 Diabetes Mellitus for at least 1 year and treated with metformin alone or metformin and one other oral anti-diabetic drug
- Body mass index between ≥19 and ≤42 kg/m2.
Exclusion Criteria
- Impaired renal function
- Clinically significant illness or clinically relevant trauma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 AZD1656 AZD1656 day 1-5, AZD1656 + Pioglitazone day 6-10, Pioglitazone day 11-15 2 AZD1656 Pioglitazone day 1-5, AZD1656 + Pioglitazone day 6-10, AZD1656 day 11-15 2 Pioglitazone Pioglitazone day 1-5, AZD1656 + Pioglitazone day 6-10, AZD1656 day 11-15 1 Pioglitazone AZD1656 day 1-5, AZD1656 + Pioglitazone day 6-10, Pioglitazone day 11-15
- Primary Outcome Measures
Name Time Method To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of AUC (0-24) and Cmax. Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
- Secondary Outcome Measures
Name Time Method To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of tmax, t1/2 and CL/F. Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate. To evaluate the pharmacokinetics of the AZD1656 and its metabolite, when AZD1656 is administered with and without pioglitazone, by assessment of AUC(0 24), Cmax and tmax. Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate. To evaluate the pharmacokinetics of the Pioglitazone metabolite hydroxyl pioglitazone, when pioglitazone is administered with and without AZD1656, by assessment of AUC(0-24), Cmax and tmax. Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
Trial Locations
- Locations (1)
Research Site
🇺🇸Chula Vista, California, United States