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This study aims to evaluate the pharmacodynamics after single oral dosing of tegoprazan, EAPA115 and RAPA115 in healthy volunteers.
Evaluation Criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 50 mg | Experimental | Oral administration of Tegoprazan 50 mg tablet once a day |
|
| EAPA115 | Active Comparator | Oral administration of EAPA115 once a day |
|
| RAPA115 | Active Comparator | Oral administration of RAPA115 once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan 50 mg | Drug | Tegoprazan 50 mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic Evaluation | The ratio of duration(Duration %) with pH ≥ 4 over 24 hours | Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period |
| Pharmacodynamic Evaluation | The ratio of duration(Duration %) with pH ≥ 6 over 24 hours | Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period |
| Pharmacodynamic Evaluation | Median pH | Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period |
| Pharmacodynamic Evaluation | Mean pH | Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period |
| Pharmacodynamic Evaluation | Baseline pH and changes in pH after the administration of investigational products (change of duration %, change of mean pH, change of median pH) | Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period |
| Pharmacodynamic Evaluation | The ratio of duration(Duration %) with pH ≥ 4 during nocturnal period* (*12 hours after administration of investigational product) | Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period |
| Pharmacodynamic Evaluation | The ratio of duration(Duration %) with pH ≥ 6 during nocturnal period* (*12 hours after administration of investigational product) |
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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 |
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| EAPA115 | Drug | EAPA115 |
|
| RAPA115 | Drug | RAPA115 |
|
| Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period |