Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fasting Conditions

Exclusion Criteria

• •1. Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
• •2. Subject with a 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
• •\*ALT or 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 of screening
• •5. Subject who smokes more than one pack of cigarette a day within 6 months of screening
• •6. Subject who took other clinical trial drugs or bioequivalence test drugs within 3 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, greater than 140 mmHg or diastolic blood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position
• •* Severe bradycardia (less than 50 beats/minute)
• •8. Subject who has significant alcohol abuse or drug abuse within a year of screening
• •9. Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug.
• •10. Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of clinical trial drug.
• •11. Subject who donated whole blood within 2 months prior to first administration of clinical trial drug or blood components within 1 month prior to first administration of clinical trial drug
• •12. Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself.
• •13. Subject had genetic dysfunctions like galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• •14. Subjects who were deemed inappropriate to participate in the study by the investigator