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An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HIP1801 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801 |
|
| Sequence 2 | Experimental | Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402 |
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| Sequence 3 | Experimental | High fat diet + HIP1402, Period 2 : High fat diet + HIP1801 |
|
| Sequence 4 | Experimental | High fat diet + HIP1801, Period 2 : High fat diet + HIP1402 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIP1402 | Drug | Tamsulosin (HanmiTams Capsule) 0.4mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour |
| AUClast of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour |
| Tmax of Tamsulosin | pharmacokinetic evaluation |
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Inclusion Criteria:
Exclusion Criteria:
1.Age 19~45 years in healthy male volunteers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea |
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| HIP1801 | Drug | Tamsulosin 0.4mg |
|
| pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour |
| t1/2 of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour |
| CL/F of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour |
| Vd/F of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour |