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Not yet recruitingNCT07114406Updated Aug 11, 2025

A Study to Evaluate Safety and Efficacy of PBK_M2502

A Phase 3 interventional study of PBK_M2502 1-Day and PBK_M2502 2-Day in Intestinal Disease, Colonic Diseases and Gastrointestinal Disease, sponsored by Pharmbio Korea Co., Ltd.. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Pharmbio Korea Co., Ltd. · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

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.

02

Conditions studied

  • Intestinal Disease
  • Colonic Diseases
  • Gastrointestinal Disease
  • Digestive System Disease
03

In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's planned enrollment of 110 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Pharmbio Korea Co., Ltd. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Experimental

    PBK\_M2502, 1-Day Regimen

    Drug: PBK_M2502 1-Day

  • Active comparator
    active Comparator

    PBK\_M2502, 2-Day Regimen

    Drug: PBK_M2502 2-Day

Interventions

  • DrugPBK_M2502 1-Day

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

  • DrugPBK_M2502 2-Day

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

06

What researchers measure

Primary outcomes

  1. Successful cleansing rate

    %Patient with HCS-graded A or B

    Time frame: Day 1 (day of colonoscopy)

Secondary outcomes

  1. Overall cleansing rate

    %Patient with each HCS-grade (A, B, C, D)

    Time frame: Day 1 (day of colonoscopy)

  2. Mean segmental cleansing score

    5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.

    Time frame: Day 1 (day of colonoscopy)

  3. Mean cecal intubation time

    Time frame: Day 1 (day of colonoscopy)

  4. Mean colonoscopy withdrawal time

    Time frame: Day 1 (day of colonoscopy)

  5. Treatment compliance

    Dosage taken/Dosage scheduled

    Time frame: Day 1 (day of colonoscopy)

  6. Patient satisfaction

    Subject questionnaire (Taste, Difficulty, Ease of taking)

    Time frame: Day 1 (day of colonoscopy)

  7. Polyp detection rate

    Time frame: Day 1 (day of colonoscopy)

07

Study locations

1 site
  • Kyung Hee University Hospital at Gangdong
    Seoul, Gangdong-gu, South Korea
    • Cha Jaemyung, Principal Investigator · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07114406
Lead sponsor
Pharmbio Korea Co., Ltd.
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Aug 2025 (estimated)
Primary completion
Aug 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Aug 11, 2025

Study contacts

Manager Clinical Trial team, Pharmbio Korea
Contact
cr@pharmbio.co.kr
+82-2-587-2551

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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