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To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Japanese_DWP14012 Amg | Experimental | DWP14012 Amg, tablets, orally, single and multiple administration |
|
| Japanese_DWP14012 Bmg | Experimental | DWP14012 Bmg, tablets, orally, single and multiple administration |
|
| Japanese_DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, single and multiple administration |
|
| Caucasian_DWP14012 Bmg | Experimental | DWP14012 Bmg, tablets, orally, single and multiple administration |
|
| Caucasian_DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, single and multiple administration |
|
| Korean_DWP14012 Bmg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 | Drug | DWP14012 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration of DWP14012 | 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h |
| Cmax,ss / Cmin,ss | Maximum / Minimum concentration of DWP14012 at steady state | 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h |
| Tmax | Time of maximum concentration | 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h |
| AUClast / AUCinf | Area under the plasma concentration-time curve | 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h |
| T1/2 | Elimination half-life | 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h |
| Percentage of total time that the intragastric pH was above 4 | After single administration of the investigational products, 24hr gastric pH monitoring started. | Day 1 |
| Percentage of total time that the intragastric pH was above 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000634065 | fexuprazan |
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DWP14012 Bmg, tablets, orally, single and multiple administration |
|
| Korean_DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, single and multiple administration |
|
| Placebo | Placebo Comparator | DWP14012 placebo-matching tablets |
|
| Placebo | Drug | DWP14012 placebo-matching tablets |
|
After single administration of the investigational products, 24hr gastric pH monitoring started. |
| Day 7 |