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This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5124 and DW5124-R, and the effect of food on DW5124, in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | cross-over |
|
| Sequence B | Experimental | cross-over |
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| Sequence C | Experimental | cross-over |
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| Sequence D | Experimental | cross-over |
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| Sequence E | Experimental | cross-over |
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| Sequence F | Experimental | cross-over |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW5124 | Drug | DW5124 on fasted or fed condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed | up to 72 hour |
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed | up to 72 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma concentration (Tmax) | Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed | up to 72 hour |
| Terminal half life (t1/2) | Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | South Korea |
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| DW5124-R | Drug | DW5124-R on fasted or fed condition |
|
| up to 72 hour |
| Apparent clearance (CL/F) | Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed | up to 72 hour |
| Apparent volume of distribution (Vd/F) | Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed | up to 72 hour |