CKD-337 Drug Interaction Study

Phase 1

Completed

• Conditions: Dyslipidemia (Fredrickson Type Ⅱb); Dyslipidemia (Fredrickson Type Ⅱa)
• Interventions: Drug: Fenofibrate; Drug: Atorvastatin

• Registration Number: NCT02066207
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-16
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-19
• Status Verified: 2014-03
• Study Start: 2014-03-18
• Primary Completion: 2014-04-07
• Study Completion: 2014-05-29
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fenofibrate and Atorvastatin	Atorvastatin	Subjects received Fenofibrate and Atorvastatin
Fenofibrate and Atorvastatin	Fenofibrate	Subjects received Fenofibrate and Atorvastatin
Fenofibrate	Fenofibrate	Subjects received Fenofibrate
Atorvastatin	Atorvastatin	Subjects received Atorvastatin

Primary Outcome Measures

Name	Time	Method
AUCt, Cmax,ss of fenofibric acid and atorvastatin	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 Measures

Name	Time	Method
Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of