Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers

Exclusion Criteria

• •1. Subject who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases
• •2. Subject with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug
• •3. Subject who shows the following values as a result of laboratory tests
• •\*Alanine Transaminase(ALT) or Aspartate Transaminase(AST) \> 2 times upper limit of normal range
• •4. Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months prior to screening
• •5. Subject who smokes more than 20 cigarettes a day within 6 months prior to screening
• •6. Subject who took other clinical trial drugs or bioequivalence test drugs within 6 months before the first administration of clinical trial drug
• •7. Subject who conform to the specific items below
• •* systolic blood pressure less than 90 mmHg, not less than 140 mmHg or diastolic blood pressure less than 60 mmHg or not less than 90 mmHg in a sitting position
• •* Severe bradycardia (less than 50 beats/minute)
• •8. Subject who has a medical history of significant alcohol abuse or drug abuse within one year prior to screening
• •9. Subject who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first administration of investigational product(s).
• •10. Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of investigational product(s).
• •11. Subject who donated whole blood within 2 months, or blood components within 1 month prior to first administration of investigational product(s).
• •12. Subject who has hypersensitivity to investigational product(s) or investigational product(s) ingredient.
• •13. Subject who does not consent to reliable contraception during the entire period of clinical trial and until 7 days after the last administration of investigational product.
• •14. Subject who were deemed to be inappropriate to participate in the study by the investigator.