A Study to Evaluate Safety and Efficacy of PBK_M2101

Study Overview
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Brief Summary
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This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.

Official Title
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A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101

Conditions
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Intestinal Disease, Colonic Diseases, Gastrointestinal Disease, Digestive System Disease

Intervention / Treatment
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* Drug: PBK_M2101 2-Day
* Drug: PBK_M2101 1-Day
* Drug: Oral Sulfate Tablet 2-Day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who is informed and give a consent in voluntary Patients who is scheduled a esophagogastroduodenoscopy and 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 Uncontrolled hypertension Uncontrolled diabetes Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance HIV infection and/or chronic hepatitis B or C Patients who has a difficulty to participate because of severe nausea or vomiting History of colon surgery and abdominal surgery within 6 month; need an emergency surgery

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test 1<br>PBK_M2101, 2-Day Regimen | Drug: PBK_M2101 2-Day<br>* Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.<br>|
| Experimental: test 2<br>PBK_M2101, 1-Day Regimen | Drug: PBK_M2101 1-Day<br>* Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.<br>|
| Active Comparator: active Comparator<br>active Comparator, 2-Day Regimen | Drug: Oral Sulfate Tablet 2-Day<br>* Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful cleansing rate | %Patient with HCS-graded A or B | From day of first dosing to day of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall cleansing rate | %Patient with each HCS-grade (A, B, C, D) | From day of first dosing to day of colonoscopy | 
| Mean segmental cleansing score | 5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum. | From day of first dosing to day of colonoscopy | 
| Mean cecal intubation time |  | From day of first dosing to day of colonoscopy | 
| Mean colonoscopy withdrawal time |  | From day of first dosing to day of colonoscopy | 
| Treatment compliance | Dosage taken/Dosage scheduled | From day of first dosing to day of colonoscopy | 
| Patient satisfaction | Subject questionnaire (Taste, Difficulty, Ease of taking) | From day of first dosing to day of colonoscopy | 
| Polyp detection rate |  | From day of first dosing to day of colonoscopy |