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A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 | Drug | Potassium-competitive acid blocker |
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| Measure | Description | Time Frame |
|---|---|---|
| Emax | up to 50 days | |
| AUEC0-24 | up to 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| DWC202202 Cmax,ss | up to 50 days | |
| DWC202202 active metabolite Cmax,ss | up to 50 days | |
| DWC202202 AUCtau,ss |
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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.
Exclusion Criteria:
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| 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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| DWC202202 | Drug | Clopidogrel Bisulfate |
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| DWC202203 | Drug | Proton pump inhibitor |
|
| up to 50 days |
| DWC202202 active metabolite AUCtau,ss | up to 50 days |
| DWC202202 AUCinf,ss | up to 50 days |
| DWC202202 active metabolite AUCinf,ss | up to 50 days |
| DWC202202 Tmax,ss | up to 50 days |
| DWC202202 active metabolite Tmax,ss | up to 50 days |
| DWC202202 t1/2,ss | up to 50 days |
| DWC202202 active metabolite t1/2,ss | up to 50 days |
| DWC202202 Cmin,ss | up to 50 days |
| DWC202202 active metabolite Cmin,ss | up to 50 days |
| DWC202202 Cavg,ss | up to 50 days |
| DWC202202 active metabolite Cavg,ss | up to 50 days |
| DWC202202 CLss/F | up to 50 days |
| DWC202202 Vd,ss/F | up to 50 days |
| DWC202202 PTF (peak to trough fluctuation) | up to 50 days |
| DWC202202 active metabolite PTF (peak to trough fluctuation) | up to 50 days |
| DWC202202 R | up to 50 days |
| DWC202202 active metabolite MR | up to 50 days |