Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1656 day 1-5, AZD1656 + Pioglitazone day 6-10, Pioglitazone day 11-15 |
|
| 2 | Experimental | Pioglitazone day 1-5, AZD1656 + Pioglitazone day 6-10, AZD1656 day 11-15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Tablets orally, twice daily for 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stanko Skrtic | AstraZeneca | Study Director |
| Elaine Watkins, DO | Profil Institute for Clinical Research, Inc. | Principal Investigator |
| Mirjana Kujacic | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chula Vista | California | United States |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C576407 | AZD1656 |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pioglitazone |
| Drug |
Tablet oral single dose for 10 days |
|
| 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. |
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |