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A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1 Treatment Group_1 | Placebo Comparator | Part1 Treatment Group_1_low dose DWP14012 injection Amg, Multiple administration, 7 days Placebo: Normal saline |
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| Part1 Treatment Group_2 | Placebo Comparator | Part1 Treatment Group_2_medium dose DWP14012 injection Bmg, Multiple administration, 7 days Placebo: Normal saline |
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| Part1 Treatment Group_3 | Placebo Comparator | Part1 Treatment Group_3_high dose DWP14012 injection Cmg, Multiple administration, 7 days Placebo: Normal saline |
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| Part2 Treatment Group | Experimental | Part2 Treatment Group_continuous intravenous administration - DWP14012 injection Dmg, Loading dose / DWP14012 injection Emg for 3 days, Maintenance dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 injection | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h of Fexuprazan | Pharmacokinetics parameter following DWP14012 injection | Part1 for 8 days, Part2 for 5 days |
| 24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%) | Parmacodynamics parameter following DWP14012 injection | Part1 for 8 days, Part2 for 4 days |
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Inclusion Criteria:
Healthy adults aged ≥ 19 and ≤ 50 years at screening
Subjects with a body weight of ≥ 55.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 and ≤ 28.0 at screening
☞ BMI(kg/m2) = weight (kg) / {Height (m)}2
Subjects who have given written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
Subjects eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, investigator questioning, etc.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Injin Jang, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul-National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| C000634065 | fexuprazan |
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