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The safety/tolerability and pharmacokinetic properties of DWJ1521 are evaluated after single intravenous administration of DWJ1521 in healthy adults.
The safety/tolerability and pharmacokinetic properties of DWJ1521 single intravenous administration and DWP14012 single oral administration in healthy adults are compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1(Cohort1) : DWJ1521 Amg | Experimental |
| |
| Part1(Cohort2) : DWJ1521 Bmg | Experimental |
| |
| Part1(Cohort3) : DWJ1521 Cmg | Experimental |
| |
| Part1(Cohort4) : DWJ1521 Dmg | Experimental |
| |
| Part2 : DWJ1521 Xmg | Experimental |
| |
| Part2 : DWP14012 Tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | 100ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%) | [Time Frame: [Time Frame: 0 - 72 hours after dosing]] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| DWJ1521 | Drug | Single dose |
|
| DWP14012 Tablet | Drug | Single dose, Tablet |
|
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| C000634065 | fexuprazan |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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