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This is a randomized, open-label study to evaluate the safety/tolerability and PK/PD drug-drug interactions between DWP14012 and aspirin when administered in combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Aspirin (substrate), DWP14012 (Perpetrator) |
|
| Cohort 2 | Experimental | DWP14012 (substrate), Aspirin (Perpetrator) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 | Drug | Potassium-competitive acid blocker |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of aspirin | Up to 21 days | |
| Cmax,ss of DWP14012 | Up to 13 days | |
| Emax | Up to 21 days | |
| AUClast of aspirin | Up to 21 days | |
| AUCÏ„,ss of DWP14012 | Up to 13 days | |
| time to Emax | Up to 21 days | |
| AUEC | Up to 21 days |
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Inclusion Criteria:
Healthy adults aged ≥ 19 and ≤ 50 years at screening
Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening
※ BMI (kg/m2) = body weight (kg)/[height (m)]2
Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
For women, negative urine pregnancy test (hCG) at the screening visit
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In Jin Jang, MD, PhD | Seoul National University | 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 |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin |
| Drug |
acetylsalicylic acid |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |