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An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HGP1602 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1 : Fasted state + HGP1812, Period 2 : Fasted state + HGP1602 |
|
| Sequence 2 | Experimental | Period 1 :Fasted state + HGP1602, Period 2 : Fasted state + HGP1812 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGP1812 | Drug | Dapagliflozin (Forxiga) 10mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |
| AUClast of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |
| Tmax of Dapagliflozin | 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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| HGP1602 |
| Drug |
Dapagliflozin 10mg |
|
| pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |
| t1/2 of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |
| CL/F of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |
| Vd/F of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |