Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers

To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers

Inclusion Criteria:

• Healthy male aged 19 to 55 years at the time of signing informed consent form.
• Subject with BMI from 19kg/m^2 to 27kg/m^2
• Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study

Exclusion Criteria:

• Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.

• Subject who fall under the criteria below in laboratory test.

  • AST/ALT, total bilirubin, GGT, Uric acid > UNL (upper normal limit) x 1.5
  • CPK > UNL x 2.5
  • CrCL < 60mL/min

• Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)