NCT06393881

UnknownPhase 1

A Study to Compare and Evaluate the Safety, Pharmacokinetics...

Korea United Pharm. Inc.Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

KUP-UI059-102

Study Type

interventional

Estimated enrollment

66

Locations

1 country

Sites

1

Timeline

Study Start

July 3, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

September 14, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 21, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

A randomized, open-label, multiple-dose crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 66 participants
Study completion date: September 21, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 28, 2024
Actual (reported)
First Posted
May 1, 2024
Actual (reported)
Study Start
July 3, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 14, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 21, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: May 1, 2024
Status Verified: April 2024
Last Update Submitted: April 28, 2024

Conditions

Gastro-Intestinal Disorder

Outcome Measures

Primary Outcomes (2)

AUCtau,ss
Area under the plasma concentration-time curve within a dosing interval at steady state
Day 1: 0~24hours / Day 5, 6: 0hours / Day 7: 0~24hours
Percent decrease from baseline in integrated gastric acidity
Percent decrease from baseline in integrated gastric acidity for 24 hours after multiple(7th dose) administrations
Day -1~Day 1, Day 1~Day 2, Day 7

Study Arms (2)

UI059

EXPERIMENTAL

Drug: UI059

UIC202201

ACTIVE COMPARATOR

Drug: UIC202201

Interventions

UI059Drug

take UI059 once a day for 7 days

Also known as: Test

UI059

UIC202201Drug

take UIC202201 once a day for 7 days

Also known as: Reference

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

healthy adult volunteers aged 19 and above.
For males, a weight of 50.0 kg or more, and for females, a weight of 45.0 kg or more, with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2.

Sponsors & Collaborators

Korea United Pharm. Inc.
Industrylead

Study Sites (1)

Chungbuk national university hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Minkyu Park, MD, PhDCONTACT+821057170713 mk_park@cbnuhctc.com

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

Minkyu Park, MD, PhD
Chungbuk National University Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Minkyu Park, MD, PhD

CONTACT

+82432698708 mk_park@cbnuhctc.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 1, 2024

Study Start

July 3, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

NCT06700785

A Pharmacokinetic Comparison of Three Butyrate Products

Not ApplicableCompleted

NCT07490132

Endoscopic Retrograde Cholangiopancreatography

Recruiting

NCT05627882

Evaluation of the Impact of a Forward Viewing Scope at Time of ERCP

Completed

NCT05159921

Can the SurgInfoBot Improve the Consent Process for Endoscopy? A Randomised Controlled Trial

Not ApplicableUnknown

NCT05371067

Fructose Effect on Neuroinflammation and Feelings

Not ApplicableCompleted

NCT07565454

Evaluation of Hepato-Pancreato-Biliary

Recruiting

UIC202201

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

BMI(kg/m2)=Weight(kg)/height(m)2

No congenital or chronic diseases requiring treatment, and no pathological symptoms or findings based on internal medicine examination.

Those who were determined to be suitable subjects for clinical trials as a result of tests such as clinical laboratory tests, vital signs, physical examination (physical examination), and 12-lead electrocardiogram

Negative for H. pylori antibodies

After receiving detailed explanations about the clinical trial and fully understanding, participants voluntarily decide to participate and provide written consent to adhere to the subject compliance requirements throughout the trial period.

You may not qualify if:

Current or past medical history of clinically significant conditions involving the liver, kidneys, nervous system, mental health, respiratory system, endocrine system, blood disorders, tumors, genitourinary system, cardiovascular system, digestive system, musculoskeletal system, etc., and in addition:
currently receiving antiretroviral drugs (rilpivirine, atazanavir, nelfinavir)
liver disorders
kidney disorders
History of gastrointestinal conditions (Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of the investigational drug.
Pregnant (positive Urine-HCG) or lactating for female participants
Have a history of hypersensitivity reactions (such as anaphylaxis or angioedema) or clinically significant hypersensitivity reactions to drugs, excipients, or other substances, including medications containing the active ingredients of the investigational drug, additives, and other drugs (such as aspirin, penicillin antibiotics, macrolide antibiotics).
Have clinically significant findings on the 12-lead electrocardiogram during screening, including:
QTc interval \> 450 ms for males or \> 470 ms for females.
PR interval \> 200 ms.
QRS duration \> 120 ms.
Showing the following results in clinical trial laboratory tests during screening:
liver function assessment: AST, ALT, ALP, γ-GTP, and total bilirubin exceeding twice the upper limit of the normal range.
Blood creatinine levels outside the reference range or calculated estimated glomerular filtration rate (eGFR) using the CKD-EPI formula less than 60 mL/min/1.73m2.
History of drug abuse or individuals who have shown a positive reaction for abused substances in a urine drug test.
+11 more criteria

Contact the study team to confirm eligibility.

September 14, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 21, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

May 1, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06393881
Data provider: ClinicalTrials.gov
Source updated: 2024-05-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:57 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

UI059

UIC202201

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations