Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801 |
|
| Sequence 2 | Experimental | Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805 |
|
| Sequence 3 | Experimental | Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801 |
|
| Sequence 4 | Experimental | Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1805 | Drug | Dapagliflozin/Metformin (Xigduo XR) 10/1000mg |
|
| 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 |
| Cmax of Metformin | 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 Metformin | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HCP1801 | Drug | Dapagliflozin/Metformin 10/1000mg |
|
| 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 |
| AUCinf of Metformin | 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 Metformin | pharmacokinetic evaluation | 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 Metformin | 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 Metformin | 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 Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |