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This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (Tablet B - Tablet A) | Experimental | Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A |
|
| Sequence 2 (Tablet A - Tablet B) | Experimental | Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 tablet A | Drug | Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval) | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour |
| Cmax: Peak concentration of DWP14012 | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf: Area under the drug concentration-time curve from time 0 to infinity | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour |
| Tmax: Time of maximum concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| DWP14012 tablet B | Drug | Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B |
|
each period
| 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour |
| t1/2: Terminal elimination half-life | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour |
| CL/F: Apperent Clearance | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour |
| Vd/F: Apparent volume of distribution | each period | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour |