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The purpose of this study is to evaluate the pharmacokinetic interaction between Atorvastatin and Fenofibric acid.
This study is a randomized, open-label, multiple dosing, 3-way crossover design to evaluate the drug-drug interaction between Atorvastatin (Lipitor) and Fenofibric (Trilipix) acid in healthy male subjects. Subjects will receive repeated dose of Atorvastatin (40mg*1Tab/day) or Fenofibric acid (135mg*1Cap/day) or Atorvastatin (40mg*1Tab/day)/Fenofibric acid (135mg*1Cap/day). Each treatment period was separated by a washout period of at least 8 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1: TreatmentA+TreatmentB+TreatmentC | Experimental | TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days. |
|
| Group2: TreatmentC+TreatmentA+TreatmentB | Experimental | TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days. |
|
| Group3: TreatmentB+TreatmentC+TreatmentA | Experimental | TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days. |
|
| Group4: TreatmentC+TreatmentB+TreatmentA | Experimental | TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipitor Tab. 40mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atorvastatin and Fenofibric acid AUCĪ | 1D~7D 19points, 1D~7D 18points, 1D~7D 20points | predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks |
| Atorvastatin and Fenofibric acid Css,max | 1D~7D 19points, 1D~7D 18points, 1D~7D 20points | predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Atorvastatin and Fenofibric acid Css,min | 1D~7D 19points, 1D~7D 18points, 1D~7D 20points | predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks |
| Atorvastatin and Fenofibric acid Css,av |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Gul Kim | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Deokjin-gu | Jeonju-si, Jeollabuk-do | 561-712 | South Korea |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D011345 | Fenofibrate |
| C006012 | fenofibric acid |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Group5: TreatmentB+TreatmentA+TreatmentC | Experimental | TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days. |
|
| Group6: TreatmentA+TreatmentC+TreatmentB | Experimental | TreatmentA: Atorvastatin 40m*1T/day, TreatmentB: Fenofibric acid 135mg*1Cap/day, TreatmentC: Atorvastatin 40m*1T/day and Fenofibric acid 135mg*1Cap/day. Each treatment period was separated by a washout period of at least 8days. |
|
|
| Trilipix 135mg | Drug |
|
|
1D~7D 19points, 1D~7D 18points, 1D~7D 20points |
| predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks |
| 2-hydroxyatorvastatin AUCĪ | 1D~7D 19points, 1D~7D 18points, 1D~7D 20points | predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks |
| 2-hydroxyatorvastatin Css,max | 1D~7D 19points, 1D~7D 18points, 1D~7D 20points | predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| 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 |