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The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | multiple dose of Rosuvastatin 20mg |
|
| Fenofibric acid | Experimental | multiple dose of Fenofibric acid 135mg |
|
| Rosuvastatin + Fenofibric acid | Experimental | multiple dose of the combination of Rosuvastatin 20mg and Fenofibric acid 135mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cresto 20mg | Drug | tablet, rosuvastatin 20mg |
| |
| Fenofibric acid 135mg |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods | |
| AUCtau | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |
| Measure | Description | Time Frame |
|---|---|---|
| Cmin | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods | |
| Tmax | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |
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Inclusion Criteria:
Exclusion Criteria:
A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
A subject who shows the following result in clinical laboratory test
Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Gook Shin, Professor | BUSAN PAIK HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University College of Medicine Busan Paik Hospital | Busan | South Korea |
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| ID | Term |
|---|---|
| C006012 | fenofibric acid |
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| Drug |
capsule, fenofibric acid 135mg |
|
| Cresto 20mg, Fenofibric acid 135mg | Drug | rosuvastatin 20mg, Fenofibric acid 135mg |
|
| CL/F | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |
| T1/2 | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |
| Metabolic Ratio | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |