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A Study to Evaluate Safety and Efficacy of PBK_M2101

NCT05923918 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2023-06-28

No results posted yet for this study

Summary

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

Conditions

  • Intestinal Disease
  • Colonic Diseases
  • Gastrointestinal Disease
  • Digestive System Disease

Interventions

DRUG

PBK_M2101 2-Day

Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.

DRUG

PBK_M2101 1-Day

Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.

DRUG

Oral Sulfate Tablet 2-Day

Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.

Sponsors & Collaborators

  • Pharmbio Korea Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Byeon, M.D. · Seoul Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-05-31
Completion
2024-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05923918 on ClinicalTrials.gov