NCT05923918

A Study to Evaluate Safety and Efficacy of PBK_M2101

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Pharmbio Korea Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2023-06-28
• Last updated: 2023-06-28

Locations

1 site across 1 country: South Korea