Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg

A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers

The objectives of this study are:

• To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
• To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers

Inclusion Criteria:

• Male volunteers in the age between 20 and 45 years old
• Body Mass Index (BMI) in the range of 19 to 27 kg/m2

Exclusion Criteria:

• History of allergy or sensitivity to any drug, including amlodipine or valsartan

• History of clinically significant hepatic, renal, gastrointestinal, neurology, pulmonary, endocrine, musculoskeletal, hematologic, oncologic, psychiatric, especially cardiovascular disease

• History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines

• Hypotension (Systolic Blood Pressure(SBP) ≤ 100 mmHg or Diastolic Blood Pressure(DBP) ≤ 65 mmHg)

• Hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)

• Clinical laboratory test values are outside the accepted normal range

  • Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 1.25 times to normal range
  • Total bilirubin > 1.25 times to normal range

• Positive for Hepatitis B Virus surface Antigen(HBsAg), Hepatitis C Virus Antibody(HCVAb) or Human Immunodeficiency Virus Antibody(HIVAb)