Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects

An open-label, multiple dose, fixed-sequence, 3-period study to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.

Inclusion criteria

• Healthy volunteers aged between ≥ 20 and ≤ 45 years old
• Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
• Subjects to consents to use effective birth controls for at least 2 months following the last dose
• Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written

Exclusion criteria

• History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder
• With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
• Any medical history that may affect drug absorption, distribution, metabolism and excretion
• Any hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of statin-related medication or Cholesteryl Ester Transfer Protein(CETP) inhibitor or other drugs(aspirin, antibiotics)
• Continuous cryptogenic elevation of serum transaminase or active liver disease including elevation of serum transaminase > 3 fold upper normal limit(UNL)
• Severe renal failure(creatinin clearance < 30 ml/min)
• Hypothyroidism or clinically significant test result
• Galactose intolerance, Lapp lactose intolerance, glucose-galactose malabsorption or genetic disorders
• Any clinically significant chronic medical illness
• Any clinically significant hypotension or hypertension (systolic < 100 mmHg/diastolic < 60 mmHg or systolic > 140 mmHg /diastolic > 90 mmHg)
• Corrected QT interval(QTc) >450msec on 12-lead ECG
• Positive blood tests for hemoglobins(HBs) Ag, anti-hepatitis C virus(HCV) Ab, anti-HIV Ab, or venereal disease research laboratory(VDRL)
• Creatine phosphokinase(CPK) ≥ 5 fold of upper normal limit(UNL)
• Use of any prescription drugs within 14 days prior to study drug administration
• Use of any other drugs, including over-the-counter medications and herbal preparations within 7 days prior to study drug administration
• History of clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not require any treatment may be allowed)
• Inability to take normal hospital diet
• Donation of blood within 60 days prior to study drug administration or plasma to a blood bank within 20 days prior to study drug administration
• Blood transfusion within 30 days prior to study drug administration
• Exposure to any investigational drug or placebo within 90 days prior to the first Investigational Product(IP) administration
• Subjects taking any drugs to induce or inhibit drug metabolizing enzymes including barbiturates within 30 days prior to the first Investigational Product(IP) administration
• Subjects with excessive caffeine intake (more than 5 cups/day), heavy smoking (more than 10 cigarettes/day), regular alcohol intake (more than 210 g/week)
• Subjects having been deemed inappropriate for the trial as determined by the investigator