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

NCT ID: NCT05282914

Last Updated: 2024-07-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-03

Study Completion Date

2021-09-01

Brief Summary

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A Study to compare pharmacokinetics, pharmacodynamics and safety of UI058 and UIC202004 in healthy subjects

Detailed Description

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Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UI058

Group Type EXPERIMENTAL

administration of UI058

Intervention Type DRUG

UI058 1Tab/day for 7days

UIC202004

Group Type ACTIVE_COMPARATOR

administration of UIC202004

Intervention Type DRUG

UIC202004 1Tab/day for 7days

Interventions

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administration of UI058

UI058 1Tab/day for 7days

Intervention Type DRUG

administration of UIC202004

UIC202004 1Tab/day for 7days

Intervention Type DRUG

Other Intervention Names

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Test Reference

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korea United Pharm. Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Kyu Park, Dr

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Locations

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Chungbuk national university hospital

Cheongju-si, North Chungcheong, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KUP-UI058-101

Identifier Type: -

Identifier Source: org_study_id

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