CKD-337(2) Drug-drug Interaction Study
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic interaction between Atorvastatin and Fenofibric acid.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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 (40mg1Tab/day) or Fenofibric acid (135mg1Cap/day) or Atorvastatin (40mg1Tab/day)/Fenofibric acid (135mg1Cap/day). Each treatment period was separated by a washout period of at least 8 days.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group1: TreatmentA+TreatmentB+TreatmentC 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. |
Drug: Lipitor Tab. 40mg
Other Names:
Drug: Trilipix 135mg
Other Names:
|
| Experimental: Group2: TreatmentC+TreatmentA+TreatmentB 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. |
Drug: Lipitor Tab. 40mg
Other Names:
Drug: Trilipix 135mg
Other Names:
|
| Experimental: Group3: TreatmentB+TreatmentC+TreatmentA 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. |
Drug: Lipitor Tab. 40mg
Other Names:
Drug: Trilipix 135mg
Other Names:
|
| Experimental: Group4: TreatmentC+TreatmentB+TreatmentA 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. |
Drug: Lipitor Tab. 40mg
Other Names:
Drug: Trilipix 135mg
Other Names:
|
| Experimental: Group5: TreatmentB+TreatmentA+TreatmentC 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. |
Drug: Lipitor Tab. 40mg
Other Names:
Drug: Trilipix 135mg
Other Names:
|
| Experimental: Group6: TreatmentA+TreatmentC+TreatmentB 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. |
Drug: Lipitor Tab. 40mg
Other Names:
Drug: Trilipix 135mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Atorvastatin and Fenofibric acid AUCτ [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]
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
- Atorvastatin and Fenofibric acid Css,max [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]
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
Secondary Outcome Measures
- Atorvastatin and Fenofibric acid Css,min [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]
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
- Atorvastatin and Fenofibric acid Css,av [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]
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
- 2-hydroxyatorvastatin AUCτ [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]
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
- 2-hydroxyatorvastatin Css,max [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]
1D~7D 19points, 1D~7D 18points, 1D~7D 20points
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy man older than 19 years at the time of screening.
-
BMI more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 55kg
-
Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
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Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
-
Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
-
Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
Exclusion Criteria:
-
Subject who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
-
Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
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Showing the value that corresponds to following laboratory parameters: AST or AST or CK > 2* upper limit of normal range.
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Alcohol > 210g/week, within 6 months prior to the screening.
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Taking the medication involved in other clinical trials within two months before the first dose medication characters.
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Sitting Systolic Blood Pressure ≥ 140 mmHg, Diastolic Blood Pressure ≥ 90 mmHg at the time of screening.
-
History of alcohol or drug abuse, within 1 year
-
Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
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Smoker (> 20cigarettes/day)
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Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
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Subject who done the whole blood donation within two months or component blood donation within 1 month within 1 month prior to the first dosing.
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Subject who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
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Subject with serious history of hypersensitivity or allergy to investigational product.
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Active liver disease.
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Muscle disease.
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Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
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Patients with severe hepatic impairment or Gallbladder Disease.
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Patients with moderate to severe renal impairment.
-
Patients experienced allergy or phototoxicity during treatment with fibrate or ketoprofen.
-
Subjects who is not able to comply with guidelines described in the protocol.
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Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chonbuk National University Hospital | Deokjin-gu | Jeonju-si, Jeollabuk-do | Korea, Republic of | 561-712 |
Sponsors and Collaborators
- Chong Kun Dang Pharmaceutical
Investigators
- Principal Investigator: Min Gul Kim, Chonbuk National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 146DDI14030