Safety and Efficacy of CDFR0612 and CDFR0613 for Bowel Cleansing Before Colonoscopy

Exclusion Criteria

• •Patients who participate in other interventional study or had participated within 30 days before screening
• •Pregnant or breast-feeding women who do not want to stop breast-feeding
• •Women of childbearing potential who do not agree with appropriate contraception during this study
• •Patients who had experienced any hypersensitivity study drug or ingredient
• •Uncontrolled hypertension
• •Arrhythmia with clinically significant findings from EKG
• •Congestive heart failure; NYHA functional class III or IV; unstable coronary artery disease; myocardiac infarction history within 6 months
• •Uncontrolled diabetes
• •Active infection except acute upper respiratory infection or local skin infection; Fever (38 °C and higher) within 1 week before study administration
• •HIV infection and/or chronic hepatitis B or C
• •Patients who has a difficulty to participate because of severe nausea or vomiting
• •Suspected or confirmed inflammatory bowel disease, toxic colon or toxic megacolon, or gastrointestinal obstruction or perforation; visible bleeding in colon
• •History of colon surgery and abdominal surgery within 6 month; need an emergency surgery
• •Colonoscopy for the following use: treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasia, and polypectomy site (e.g.,electrocoagulation, heater probe, laser or injection therapy); foreign body removal; decompression of acute nontoxic megacolon or sigmoid volvulus; balloon dilation of stenotic lesions (e.g., anastomotic strictures); palliative treatment of stenosing or bleeding neoplasms (e.g., laser, electrocoagulation, stenting)
• •Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
• •Severe dehydration risk (e.g., rhabdomyolysis, ascites)
• •Dialysis or renal disorder (creatinine clearance \<15ml/min)
• •Suspected pulmonary aspiration or gag reflex disorder
• •History of hypersensitivity of drug or others
• •Alcohol or drug abuse within 6 months
• •Clinically significant underlying disease or medical history at investigator's discretion
• •Inability in written/verbal communication