Bioequivalence Study of CJ-30060 in Healthy Volunteers

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CJ-30060 in Healthy Subjects

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor® 10mg in healthy volunteers.

The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor® 10mg in healthy volunteers.

Inclusion Criteria:

• Healthy volunteers aged 20 to 45 years at screening
• BMI: 18~29.9kg/㎡
• Body weight ≥50kg
• Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding

Exclusion Criteria:

• Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease

• Subjects who have symptoms of an acute disease within 28days before first administration

• Subjects who have clinically significant active, chronic disease

• Subjects who fall under the criteria below in laboratory test

  • AST/ALT > UNL (upper normal limit) × 2
  • Total bilirubin > UNL × 1.5
  • CrCL < 50mL/min
  • CPK > UNL × 2.5

• Subjects with clinically significant low blood pressure at screening test(systolic blood presure is less than 100mmHg or diastolic blood pressure is less than 60mmHg)

• Subjects with any positive reaction in HBsAg, anti-HCV Ab, anti HIV Ab, VDRL tests