A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function

Exclusion Criteria

• •\[The subjects with impaired hepatic function\]
• •1. The subjects with impaired hepatic function as Child-Pugh C
• •2. The subjects had a portosystemic shunt surgery
• •3. The subjects had a liver transplantation or unsuitable for the study by the investigator's judgement(for examples, hepatic encephalopathy grade 3 or 4, stroke, heart failure, cancer etc.) but The subject is eligible to participate if had not chemotherapy or radiofrequency ablation therapy within 6months)
• •4. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
• •5. The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1
• •6. Positive for anti-HIV Ab or venereal disease research laboratory etc.
• •\[The subjects with normal hepatic function\]
• •1. The subjects with liver disease or abnormal Laboratory test(Asparate transaminase \>1.25 fold of upper normal limit, Alanine transaminase\>1.25 fold of upper normal limit, Total bilirubin \>1.5 fold of upper normal limit)
• •2. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
• •3. Estimated Glomerular filtration rate \< 60 mL/min/1.73m2 by Modification of Diet in Renal Disease formula
• •4. Positive for HBsAg, anti-Hepatitis C virus Ab, anti-HIV Ab or venereal disease research laboratory
• •5. The subjects with high blood pressure or low blood pressure(systolic blood pressure \>150mmHg or \<100mmHg, diastolic blood pressure\>90mmHg or \<60mmHg)
• •6. The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1 etc.