Back to resultsCKD-337 Drug Interaction Study
Primary Purpose
Dyslipidemia (Fredrickson Type Ⅱa), Dyslipidemia (Fredrickson Type Ⅱb)
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fenofibrate
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia (Fredrickson Type Ⅱa)
Eligibility Criteria
Inclusion Criteria:
- A healthy male volunteer between 19 and 55 years old.
- BMI between 18.5 and 27.
- Able to participate in the entire trial
- Signed the informed consent form prior to study participation.
Exclusion Criteria:
- Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system
- sit SBP < 100mmHg or sit SBP ≥ 150mmHg or sit DBP < 70mmHg or sit DBP ≥ 100mmHg
- Have acute infection history within 14 days
- Have a allergic disease of need to treat
- Have hypersensitivity reactions history for IP or any specific drugs.
- AST, ALT or Total bilirubin > UNL * 1.5
- Estimated GFR < 60 ml/min
- Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- A heavy smoker (cigarette > 10 cigarettes per day)
- A heavy alcohol consumer (alcohol > 140g/week)
- A heavy grapefruit consumer (more than 1cup per a day)
- Have a history of drug abuse or showed a positive for urine drug test.
- Administrated IP within 60 days prior to screening
- Rhabdomyolysis include of having a history or family history of genetic muscle diseases
- Positive for HIV antibody, HBsAg, HCV antibody test
- Previously donate whole blood within 60 days or component blood within 30 days
- Subject takes ethical drug or herbal medicine within 30 days
- Clinically significant laboratory test result
- An impossible one who participates in clinical trial by investigator's decision including other reason
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Fenofibrate
Atorvastatin
Fenofibrate and Atorvastatin
Arm Description
Subjects received Fenofibrate
Subjects received Atorvastatin
Subjects received Fenofibrate and Atorvastatin
Outcomes
Primary Outcome Measures
AUCt, Cmax,ss of fenofibric acid and atorvastatin
Secondary Outcome Measures
Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation
Full Information
NCT ID
NCT02066207
First Posted
February 16, 2014
Last Updated
August 7, 2017
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT02066207
Brief Title
CKD-337 Drug Interaction Study
Official Title
Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 18, 2014 (Actual)
Primary Completion Date
April 7, 2014 (Actual)
Study Completion Date
May 29, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia (Fredrickson Type Ⅱa), Dyslipidemia (Fredrickson Type Ⅱb)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fenofibrate
Arm Type
Experimental
Arm Description
Subjects received Fenofibrate
Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Subjects received Atorvastatin
Arm Title
Fenofibrate and Atorvastatin
Arm Type
Experimental
Arm Description
Subjects received Fenofibrate and Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
AUCt, Cmax,ss of fenofibric acid and atorvastatin
Time Frame
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h
Secondary Outcome Measure Information:
Title
Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation
Time Frame
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A healthy male volunteer between 19 and 55 years old.
BMI between 18.5 and 27.
Able to participate in the entire trial
Signed the informed consent form prior to study participation.
Exclusion Criteria:
Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system
sit SBP < 100mmHg or sit SBP ≥ 150mmHg or sit DBP < 70mmHg or sit DBP ≥ 100mmHg
Have acute infection history within 14 days
Have a allergic disease of need to treat
Have hypersensitivity reactions history for IP or any specific drugs.
AST, ALT or Total bilirubin > UNL * 1.5
Estimated GFR < 60 ml/min
Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
A heavy smoker (cigarette > 10 cigarettes per day)
A heavy alcohol consumer (alcohol > 140g/week)
A heavy grapefruit consumer (more than 1cup per a day)
Have a history of drug abuse or showed a positive for urine drug test.
Administrated IP within 60 days prior to screening
Rhabdomyolysis include of having a history or family history of genetic muscle diseases
Positive for HIV antibody, HBsAg, HCV antibody test
Previously donate whole blood within 60 days or component blood within 30 days
Subject takes ethical drug or herbal medicine within 30 days
Clinically significant laboratory test result
An impossible one who participates in clinical trial by investigator's decision including other reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wooseong Huh, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
CKD-337 Drug Interaction Study
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