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To evaluate the bioavailability of a tablet of AZD1656.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | AZD1656 tablet + food |
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| 2 | Active Comparator | AZD1656 susp. without food |
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| 3 | Active Comparator | AZD1656 tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Single dose oral tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F) | Blood samples taken up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic variables (Plasma glucose) | Taken repeatedly during treatment periods | |
| Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) | Taken during treatment periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klas Malmberg, MD, PhD, Prof | AstraZeneca R&D Mölndal | Study Director |
| Emanuel P DeNoia, MD | Healthcare Discoveries LLC Icon Development Solutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | San Antonio | Texas | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C576407 | AZD1656 |
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| AZD1656 |
| Drug |
Single dose oral suspension |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |