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An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903 |
|
| Sequence 2 | Experimental | Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGP1910 | Drug | Take it once per period. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| AUClast of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| Cmax of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| AUClast of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| AUClast of Total Ezetimibe | pharmacokinetic evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea |
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| HGP1909 |
| Drug |
Take it once per period. |
|
| HCP1903 | Drug | Take it once per period. |
|
| pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| AUCinf of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| Tmax of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| t1/2 of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| CL/F of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| Vd/F of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| AUCinf of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| Tmax of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| t1/2 of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| CL/F of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| Vd/F of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| AUCinf of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| Tmax of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| t1/2 of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| CL/F of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |
| Vd/F of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |