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This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in patients with mild renal impairment compared to their sex, age and weigh based healthy volunteer counterparts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug | 16 volunteers in each group of mild renal impairment patients and their matched healthy volunteers will receive once daily doses of 100mg LAF237 for 14 days. |
|
| 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:
For renal insufficient patients only
For healthy subjects only
Exclusion Criteria:
Subjects meeting any of the following criteria during screening or baseline evaluations will be excluded from entry into or continuation in the study:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| NOVARTIS | Novartis investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Kiel | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |