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To investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers
The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1 : HCP0605+HGP0816 Period 2 : HCP1305 |
|
| Sequence B | Experimental | Period 1 : HCP1305 Period 2 : HCP0605+HGP0816 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP0605 + HGP0816 | Drug |
| ||
| HCP1305 |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | Area under the curve to the last measurable concentration | pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours |
| Cmax | Peak Plasma Concentration | pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | Area under the curve to infinity | pre-dose(0h), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours |
| Tmax | Time to maximum concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | South Korea |
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|
| pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours |
| T1/2 | Terminal elimination half-life | pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours |
| Cl/F | Apparent clearance | pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours |
| Vz/F | Apparent volume of distribution | pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours |