Comparative Evaluation of Pharmacokinetics After CKD-501 Between Renal Impaired and Normal Renal Function Subjects

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

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)