A Study to Evaluate Safety and Efficacy of PBK_M2101

Pharmbio Korea

Status and phase: Enrolling; Phase 3

Conditions: Gastrointestinal Disease; Intestinal Disease; Colonic Diseases; Digestive System Disease

Treatments: Drug: Oral Sulfate Tablet 2-Day; Drug: PBK_M2101 2-Day; Drug: PBK_M2101 1-Day

Study type: Interventional

Funder types: Industry

Identifiers

NCT05923918

PBK_M2101_301

Details and patient eligibility

About

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

Enrollment: 246 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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246 participants in 3 patient groups

test 1

Experimental group

Description:

PBK_M2101, 2-Day Regimen

Treatment:

Drug: PBK_M2101 2-Day

test 2

Experimental group

Description:

PBK_M2101, 1-Day Regimen

Treatment:

Drug: PBK_M2101 1-Day

active Comparator

Active Comparator group

Description:

active Comparator, 2-Day Regimen

Treatment:

Drug: Oral Sulfate Tablet 2-Day