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A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 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 |
|---|---|---|
| Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] | |
| Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Measure | Description | Time Frame |
|---|---|---|
| Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] | |
| Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing |
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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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| DWC202201 | Drug | Atorvastatin Calcium Trihydrate |
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| [Time Frame: up to 64 days] |
| Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Accumulation ratio after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite metabolic ratio after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite metabolic ratio after multiple dosing | [Time Frame: up to 64 days] |