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This study aims to evaluate the influence of tegoprazan or RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers.
[Pharmacokinetic Assessments] : Blood concentration of atorvastatin, 2-OH atorvastatin
[Sefety Assessments]
: Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin 40 mg | Placebo Comparator | Oral administration of Atorvastatin 40 mg tablet once daily for 7 days |
|
| Atorvastatin 40 mg + Tegoprazan 50 mg | Experimental | Oral administration of Atorvastatin 40 mg tablet and Tegoprazan 50 mg tablet once daily for 7 days |
|
| Atorvastatin 40 mg + RAPA114 | Active Comparator | Oral administration of Atorvastatin 40 mg tablet and RAPA114 tablet once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 40 mg | Drug | Atorvastatin 40 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCτ of atorvastatin | Area under the plasma drug concentration-time curve at steady state | Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period |
| Css,max of atorvastatin | Maximum concentration of drug in plasma of atorvastatin at steady state | Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period |
| Measure | Description | Time Frame |
|---|---|---|
| Tss,max of atorvastatin | Time to Cmax at steady state | Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period |
| AUCτ of 2-OH atorvastatin | Area under the plasma drug concentration-time curve at steady state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-ryul Kim | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| C000631239 | tegoprazan |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Tegoprazan 50 mg | Drug | Tegoprazan 50 mg tablet |
|
|
| RAPA114 | Drug | RAPA114 tablet |
|
| Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period |
| Css,max of 2-OH atorvastatin | Maximum concentration of drug in plasma of 2-OH atorvastatin at steady state | Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period |
| metabolic ratio | AUCτ of 2-OH atorvastatin / AUCτ of atorvastatin | Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |