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An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704 |
|
| Sequence 2 | Experimental | Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGP1810 | Drug | HGP1810: Vildagliptin/Metformin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| AUClast of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| Cmax of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| AUClast of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| Tmax of Vildagliptin | pharmacokinetic evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metro hospital | Anyang | South Korea |
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| HCP1704 |
| Drug |
HCP1704: Vildagliptin/Metformin |
|
| pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| t1/2 of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| CL/F of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| Vd/F of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| AUCinf of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| Tmax of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| t1/2 of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| CL/F of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |
| Vd/F of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |