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to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1_test group | Experimental | IV injection of test drugs by dose group |
|
| Part1_placebo group | Placebo Comparator | IV injection of test drugs by dose group |
|
| Part2 | Experimental | All Participants take IV injection of test drugs |
|
| Part3_test group | Experimental | In the case of test group, take IV injection in the period 1 and take a tablet in the period 2 |
|
| Part3_reference group | Active Comparator | In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexuprazan Injection | Drug | 20/40/80 mg |
| |
| Fexuprazan Injection placebo |
| Measure | Description | Time Frame |
|---|---|---|
| PK of Fexuprazan | 1. Blood and urinary concentrations of Fexuprazan by part | 0 and 72hour |
| PK of metabolite | 1. Blood and urinary concentrations of metabolite by part | 0 and 72hour |
| PD of Fexuprazan | pH monitoring | up to 15days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujong Lee, Ph.D | Contact | 027408910 | leesj0323@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Injin zhang, Ph.D | Seoul National University College of Medicine and Hospital | Principal Investigator |
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| Drug |
20/40/80 mg |
|
| Fexuprazan Injection_part 2 | Drug | 20mg |
|
| Fexuprazan Injection_part 3 | Drug | 40mg |
|
| Fexuprazan tablet | Drug | 40mg |
|
| ID | Term |
|---|---|
| C000634065 | fexuprazan |
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