Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

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

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.

The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.

Inclusion Criteria:

• Healthy males aged 20 to 45 years at screening
• BMI: 18 ~ 29.9kg/m^2
• 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 28 days 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) x 2
  • Total bilirubin > UNL x 1.5
  • CrCL < 50mL/min
  • CPK > UNL x 2.5

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

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