Clinical Study to Compare the Pharmacokinetics and Safety of D113 With CKD-349 in Healthy Volunteers

Exclusion Criteria

• •1. Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
• •2. Individuals with symptoms of acute disease within 28 days prior to the scheduled date of first administration of the investigational product
• •3. Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
• •4. Individuals with a medical history or current symptoms that fall under one or more of the following who are judged to be concerned about the use of investigational product
• •* Individuals with hypersensitivity to investigational products or the investigational products ingredients
• •* Angiotensin-converting enzyme(ACE) inhibitors are being administered or less than 36hr after discontinuation.
• •* Individuals with history of vascular edema in angiotensin-converting enzyme(ACE) inhibitors or angiotensin receptor blocker(ARB) administration
• •* Individuals with genetic or idiopathic angioedema
• •* Individuals with liver cirrhosis or atresia of bile ducts or cholestasis
• •* Individuals with primary hyperaldosteronism
• •5. Following vital signs results at screening
• •* Sitting systolic blood pressure \> 140 mmHg or \< 90 mmHg
• •* Sitting diastolic blood pressure \> 90 mmHg or \<60 mmHg
• •6. Individuals with the following results at screening test:
• •* AST(GOT) or ALT(GPT) \> 2x the upper limit of the normal range
• •* Creatinine \> upper limit of the normal range or eGFR with MDRD \<60 ml/min/1.73 m2
• •* K \> 5.5mEq/l
• •* Positive reaction on serum test(PRP Ab, anti HIV(AIDS), HBs Ag, HCV Ab)
• •7. Individuals with a medical history of significant drug abuse or positive for abuse drug in urine test results at screening
• •8. Individuals who had taken ethical(ETC) or over the counter(OTC) within the 10 days prior to the first dose of investigational product
• •9. Individuals who donated whole blood within the 8 weeks, or donated blood components within 4 weeks prior to the first dose of the investigational product or received a blood transfusion with 4 weeks
• •10. Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
• •11. Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 1 month before the first administration of clinical trial drug
• •12. Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3 months prior to first dose of this study or cannot quit drinking during clinical trials period
• •13. A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml of pure alcohol) prior to screening or individuals who cannot quit drinking from 48hr prior to the first dose to end of last blooding (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
• •14. Individuals who exceed the smoking amount of 10 cigarettes per day within 3 months prior to first dose of this study or cannot quit smoking during clinical trials period
• •15. Individuals who cannot eat standard meal in institution
• •16. Individuals who were deemed to be inappropriate to participate in the study by the investigator