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The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and sitagliptin in single and multiple doses.
All subjects will be enrolled at one center and confined to the unit for up to 17 days. Subjects will be dosed in the fasting state in one of the four groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Regimen 1 | Experimental |
| |
| Dosing Regimen 2 | Experimental |
| |
| Dosing Regimen 3 | Experimental |
| |
| Dosing Regimen 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1941 | Drug | oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables assessment through analysis of blood samples | Day 1 to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic variables assessment through analysis of blood and urine samples | Day -1 and up to Day 11 | |
| Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations | Day 1 through scheduled group check out (Day 11 and up to Day 15) or early termination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33014 | United States |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| sitagliptin | Drug | oral tablet |
|
|
| D011719 |
| Pyrazines |