CKD-337 Drug Interaction Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-18

Study Completion Date

2014-05-29

Brief Summary

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The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.

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Detailed Description

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Conditions

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Dyslipidemia (Fredrickson Type Ⅱa) Dyslipidemia (Fredrickson Type Ⅱb)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fenofibrate

Subjects received Fenofibrate

Group Type EXPERIMENTAL

Fenofibrate

Intervention Type DRUG

Atorvastatin

Subjects received Atorvastatin

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Fenofibrate and Atorvastatin

Subjects received Fenofibrate and Atorvastatin

Group Type EXPERIMENTAL

Fenofibrate

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Interventions

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Fenofibrate

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes