Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03509220
Eligibility Criteria:
Inclusion Criteria:
* Patients who is informed and give a consent in voluntary
* Patients who is scheduled a colonoscopy
* BMI 19≤and\<30
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)
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03509220
Study Brief:
Protocol Section:
NCT03509220