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This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers
Primary Outcome Measure:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 50mg under fasting condition | Experimental | Treatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day |
|
| Tegoprazan 50mg before the meal | Experimental | Treatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day |
|
| Tegoprazan 50mg after the meal | Experimental | Treatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan 50mg | Drug | K-CAB |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of tegaprazan | Area under the plasma concentration versus time curve of tegoprazan | Pre-dose(0 hour) and up to 48 hours in each period |
| Cmax of tegaprazan | Peak Plasma Concentration of tegoprazan | Pre-dose(0 hour) and up to 48 hours in each period |
| Gastric pH | Gastric pH | Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Jin Jang, MD, PhD | Seoul National University Hospital, Dept. of Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital, Clinical Trial Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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