CKD-337 Drug Interaction Study

• Status: Completed
• Trial end date: 2014-05-29
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Atorvastatin; Atorvastatin Calcium; Fenofibrate

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