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This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Vildagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| • Pharmacokinetic measures | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| • Safety and tolerability measures | throughout the study |
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Inclusion Criteria (general):
Inclusion Criteria (for renal insufficient patients):
Inclusion Criteria (for healthy subjects):
oral body temperature between 35.0-37.2 °C systolic blood pressure, 100-140 mm Hg diastolic blood pressure, 60-110 mm Hg pulse rate, 45-90 bpm
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis investigative site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Miami | Florida | 33136 | United States | ||
| Novartis Investigator Site |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| C475520 | 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Orlando |
| Florida |
| 32809 |
| United States |
| Novartis Investigator Site | Minneapolis | Minnesota | 55404 | United States |
| Novartis Investigator Site | Knoxville | Tennessee | 37920 | United States |
| Novartis Investigator Site | Richmond | Virginia | 23298 | United States |
| Novartis Investigator Site | Kiel | Germany |
| D006571 |
| Heterocyclic Compounds |