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To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers
An Open-label, Randomized, Single-dose, Crossover Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 |
|
| Group 2 | Experimental | Group 2 |
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| Group 3 | Experimental | Group 3 |
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| Group 4 | Experimental | Group 4 |
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| Group 5 | Experimental | Group 5 |
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| Group 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN-C004 with water | Drug | One time dose of IN-C004 taken with water |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of tegoprazan | Area under the plasma concentration-time curve of tegoprazan | pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours |
| Cmax of tegoprazan | Maximum Plasma Concentration at Steady State of tegoprazan | pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours |
| AUCt of tegoprazan metabolite M1 | Area under the plasma concentration-time curve of tegoprazan metabolite M1 | pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hour |
| Cmax of tegoprazan metabolite M1 | Maximum Plasma Concentration at Steady State of tegoprazan metabolite M1 | pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min-Gul Kim | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | South Korea |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Group 6
|
|
| IN-C004 without water | Drug | One time dose of IN-C004 taken without water |
|
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| K-CAB tab. with water | Drug | One time dose of K-CAB tab. taken with water |
|
|
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |