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The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1 | Active Comparator | DWP14012 Tablet A : single/multiple dose, 1 group, 2 period study |
|
| Part2 | Active Comparator | DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 Tablet A | Drug | DWP14012 10mg |
| |
| DWP14012 Tablet B |
| Measure | Description | Time Frame |
|---|---|---|
| (part 2) AUC last of DWP14012 | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing | |
| (part 2) Cmax of DWP14012 | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| (Part 2) AUC inf of DWP14012 | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing | |
| (Part 2) Tmax of DWP14012 | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with medical history that can not be participated
Subjects with results of lab tests performed at screening which meet any of the following :
subject who is allergic to IP
subject with history of serious alcohol or drug abuse within 1 year prior to screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang CHA Medical Center | Seongnam-si | Gyeonggi-do | South Korea |
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| Drug |
DWP14012 40mg |
|
| (Part 2) t1/2 of DWP14012 | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing |
| (part 1-period 1) AUC last of DWP14012 | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours |
| (part 1-period 1) Cmax of DWP14012 | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours |
| (part 1- period 2) AUC last of DWP14012 | 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8 |
| (part 1- period 2) Cmax of DWP14012 | 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8 |