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To evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap. 160mg and Livalo tab. 2mg through 3 period by separately or combinedly.
To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae Pharm. through 3 period by separately or combinedly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micronized fenofibrate | Experimental |
| |
| pitavastatin Ca | Experimental |
| |
| micronized fenofibrate plus pitavastatin Ca | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micronized fenofibrate 160mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Drug-Drug interaction evaluation (Cmax,ss, Cmin,ss, Tmax,ss) | just before dosing on 1st day and 4th day of each period and 0, 0.25, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48hr on final 5th dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Participants will be followed for the duration of study medication dosing days and hospital stay, and expected average of 3days and follow-up period for maximum 7 days from the discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| C108475 | pitavastatin |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| pitavastatin Ca 2mg |
| Drug |
|
|
| micronized fenofibrate 160mg plus pitavastatin Ca 2mg | Drug |
|
|
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |