comparative evaluation of pharmacokinetics after ckd-501 between renal impaired and normal renal function subjects

Conditions: Renal Impairment; Healthy

Summary: the purpose of this study is to assess between the renal impaired patients and normal renal function subjects comparetive evaluation to pharmacokinetics after ckd-501 future, when prescription ckd-501 to renal impaired patient, it will be guidelines to provide a basis of instructions.

a phase 1, non-randomized, open, parallel-group clinical trial

Eligibility criteria:
inclusion criteria all subjects: * adult males or females, 20 - 65 years of age (inclusive); * body mass index (bmi) range of approximately 18.5-29.9 kg/㎡ (inclusive); * agreement with written informed consent * agree to medically acceptable method of contraception during clinical trials normal renal function subjects: * matched to renal impaired patients(esrd) in the study by age (±7 years), sex and bmi * medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, ekg, physical examination); * egfr ≥ 90 ml/min/1.73me2; renally impaired subjects: * matched to renal impaired patients(esrd) in the study by age (±7 years), sex and bmi * subjects with mild renal impairment (egfr 60-89 ml/min/1.73me2) or moderate renal impairment (egfr 30-59 ml/min/1.73me2) or severe renal impairment (egfr 15-29 ml/min/1.73me2) or dialysis end stage renal disease(esrd) exclusion criteria all subjects: * the subject's systolic blood pressure is outside the range of 100-180mmhg, or diastolic blood pressure is outside the range of 50-110mmhg * repeatedly screening ecg parameters (pr ≥ 210 mse,qrs ≥ 120 msec, qtcf ≥ 500 msec) * repeatedly lab(ast \>1.25xuln, alt\>1.25xuln ,total bilirubin \>1.5xuln) * a positive pre-study drug screen.(amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepin) * clinically significant allergic diseases or history of thiazolidinedione class's anaphylaxis reactions * can not stop to be taking caffeine (caffeine \> 400mg/day), drinking(alcohol \> 30 g/day) or severe heavy smoker(cigarette \> 10 cigarettes/day) during clinical trials * consumption of food which may affect study within 7 days prior to first dose of study medication or taking a dietary supplement now or continued. * consumption of drug which may affect study within 7 days prior to first dose of study medication. * previously donate whole blood within 60 days or component blood within 30 days prior to first dose of study medication. * blood transfusion within 30 days prior to first dose of study medication. * subjects with participation in another clinical trial within 60 days prior to the study * an impossible one who participates in clinical trial by principal investigator's decision normal renal function subjects: * subjects with a history of chronic disease or an acute illness within 28 days of study medication administration * subjects with a history of gastrointestinal disease effected study medication or surgery(except appendectomy, hernia surgery) * current or chronic history of liver disease or ascites or hepatic encephalopathy renally impaired subjects: * type i diabetes, diabetic ketoacidosis, diabetic coma or a history of coma (controllable type ii diabetes including possible) * uncontrollable hypertension or severe heart failure * require treatment with steroid or immunosuppressive drug * history of renal transplant or undergoing other dialysis method except hemodialysis * needs treatment for acute disease, uncontrolled other disease or diabetic complications * current or chronic history of liver disease or ascites or hepatic encephalopathy * subjects with a history of chronic disease or an acute illness within 28 days of study medication administration * subjects with a history of gastrointestinal disease effected study medication or surgery(except appendectomy, hernia surgery)