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The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hepatic impairment group | Experimental | Mild hepatic impairment group by Child-Pugh scores |
|
| Moderate hepatic impairment group | Experimental | Moderate hepatic impairment group by Child-Pugh scores |
|
| Healthy volunteers | Active Comparator | Gemigliptin dosing in Healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin | Drug | Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Blood samples will be prepared at planed points. | Several time points until 72hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services | Kiel | Schleswig-Holstein | 24105 | Germany |
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|
| ID | Term |
|---|---|
| C534891 | LC15-0444 |
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