A Study to Compare PK, PD and Safety of UI058 and UIC2020... | NCT05282914

Studies
A Study to Compare PK, PD and Safety of UI058 and UIC202004 in Healthy Subjects

NCT05282914

Sponsor

Korea United Pharm. Inc.

Status

Completed

Last Update Posted

Jul 3, 2024Actual

Enrollment

41Actual

Phase

Phase 1

Conditions

GERD

Interventions

administration of UI058
administration of UIC202004

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2021Actual

Primary Completion Date

Apr 14, 2021Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Jan 5, 2022

First Submission Date that Met QC Criteria

Mar 7, 2022

First Posted Date

Mar 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UI058	Experimental		Drug: administration of UI058
UIC202004	Active Comparator		Drug: administration of UIC202004

Interventions

Name	Type	Description	Arm Group Labels	Other Names
administration of UI058	Drug	UI058 1Tab/day for 7days	UI058	Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state	evaluation PK for Rabeprazole after multiple dose	Day 7, 0~24hours
percent change from baseline in integrated gastric acidity for 24-hour interval after 7th dose	evaluation PD for ambulatory 24hour pH monitor	baseline versus multiple dose during 7days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects able to read and understand a written informed consent, and willing to decide to participate in the study
Healthy subjects between the ages of 19 and 55 years at screening
Body weight more than 50.0kg(male)/45.0kg(female)
Body Mass Index more than 18.0kg/m2 and under 30.0kg/m2

Exclusion Criteria:

Have clinically significant disease that hepatobiliary system, kidney, respiratory system, nervous system, hemato-oncology disease, cardiovascular system
Have a gastrointestinal disease history that can effect drug absorption or surgery
Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Min Kyu Park, Dr	Chungbuk National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chungbuk national university hospital		Cheongju-si	North Chungcheong	KS001	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided