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drug-drug interaction between DWP14012 and three different kinds of NSAIDs
to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, A (DWP14012/Celecoxib) | Experimental | Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated. |
|
| Cohort 1, B (DWP14012/Celecoxib) | Experimental | Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated. |
|
| Cohort 2, C (DWP14012/Naproxen) | Experimental | Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated. |
|
| Cohort 2, D (DWP14012/Naproxen) | Experimental | Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated. |
|
| Cohort 3, E (DWP14012/Meloxicam) | Experimental | Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 | Drug | DWP14012 40mg, bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arm A, Cmax,ss of Celecoxib | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) |
| Arm A, AUCτ,ss of Celecoxib | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) |
| Arm B, Cmax,ss of DWP14012 | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) |
| Arm B, AUCτ,ss of DWP14012 | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) |
| Arm C, Cmax,ss of Naproxen | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) |
| Arm C, AUCτ,ss of Naproxen | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) |
| Arm D, Cmax,ss of DWP14012 | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jang In-Jin, MD, PhD | Contact | +82-2-2072-1910 | ijjang@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jang In-Jin, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38700290 | Derived | Won H, Kim E, Chae J, Lee H, Cho JY, Jang IJ, Chung JY, Kim MG, Lee S. Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males. Clin Transl Sci. 2024 May;17(5):e13798. doi: 10.1111/cts.13798. |
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| ID | Term |
|---|---|
| C000634065 | fexuprazan |
| D000068579 | Celecoxib |
| D009288 | Naproxen |
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Cohort 3, F (DWP14012/Meloxicam) |
| Experimental |
Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated. |
|
| Celecoxib | Drug | Celecoxib 200mg, bid |
|
| Naproxen | Drug | Naproxen 500mg, bid |
|
| Meloxicam | Drug | Meloxicam 15mg, qd |
|
| Arm D, AUCτ,ss of DWP14012 | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours) |
| Arm E, Cmax,ss of Meloxicam | Maximum measured plasma concentration at steady-state | Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours) |
| Arm E, AUCτ,ss of Meloxicam | Area under the plasma concentration-time curve | Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours) |
| Arm D, Cmax,ss of DWP14012 | Maximum measured plasma concentration at steady-state | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours) |
| Arm D, AUCτ,ss of DWP14012 | Area under the plasma concentration-time curve | Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours) |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D013843 | Thiazines |
| D013844 | Thiazoles |