Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
246 participants
INTERVENTIONAL
2023-06-30
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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test 1
PBK\_M2101, 2-Day Regimen
PBK_M2101 2-Day
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
test 2
PBK\_M2101, 1-Day Regimen
PBK_M2101 1-Day
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
active Comparator
active Comparator, 2-Day Regimen
Oral Sulfate Tablet 2-Day
Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.
Interventions
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PBK_M2101 2-Day
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
PBK_M2101 1-Day
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
Oral Sulfate Tablet 2-Day
Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.
Eligibility Criteria
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Inclusion Criteria
* Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy
* BMI 19≤and\<30
Exclusion Criteria
* 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
19 Years
ALL
Yes
Sponsors
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Pharmbio Korea Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Byeon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul Asan Medical Center
Locations
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Seoul Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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PBK_M2101_301
Identifier Type: -
Identifier Source: org_study_id
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