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This study aims to evaluate the pharmacokinetic (PK) interaction between tegoprazan and non-steroidal anti-inflammatory drugs (NSAIDs) after given each alone and in their combination in healthy male adults.
A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 50 mg | Active Comparator | Multiple doses of tegoprazan alone once daily (QD) for 7 days |
|
| NSAIDs | Active Comparator | Multiple doses of NSAIDs alone twice daily (BID) for 7 days |
|
| Tegoprazan 50 mg + NSAIDs | Active Comparator | Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan | Drug | Tegoprazan 50 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„ of tegoprazan and NSAIDs | Area under the plasma concentration-time curve during a steady-state dosing interval (Ï„) of tegoprazan and NSAIDs | pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7 |
| Css,max of tegoprazan and NSAIDs | Maximum Plasma Concentration at Steady State of tegoprazan and NSAIDs | pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min-Gul Kim, MD, PhD | Chonbuk university hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35787943 | Derived | Moon SJ, Shin N, Kang M, Kim B, Kim MG. Pharmacokinetic Interactions Between Tegoprazan and Naproxen, Aceclofenac, and Celecoxib in Healthy Korean Male Subjects. Clin Ther. 2022 Jul;44(7):930-944.e1. doi: 10.1016/j.clinthera.2022.06.002. Epub 2022 Jul 1. |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D009288 | Naproxen |
| C056498 | aceclofenac |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Naproxen | Drug | Naproxen 500 mg tablet |
|
|
| Aceclofenac | Drug | Aceclofenac 100 mg tablet |
|
|
| Celecoxib | Drug | Celecoxib 200 mg capsule |
|
|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |