CKD-337 Drug Interaction Study

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia (Fredrickson Type Ⅱb); Dyslipidemia (Fredrickson Type Ⅱa)

Treatments: Drug: Fenofibrate; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02066207

146DDI13024

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Fenofibrate

Experimental group

Description:

Subjects received Fenofibrate

Treatment:

Drug: Fenofibrate

Atorvastatin

Experimental group

Description:

Subjects received Atorvastatin

Treatment:

Drug: Atorvastatin

Fenofibrate and Atorvastatin

Experimental group

Description:

Subjects received Fenofibrate and Atorvastatin

Treatment:

Drug: Atorvastatin

Drug: Fenofibrate