NCT05282914

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
Last Updated

July 3, 2024

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

January 5, 2022

Last Update Submit

July 2, 2024

Conditions

GERD

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

UI058

EXPERIMENTAL
Drug: administration of UI058

UIC202004

ACTIVE COMPARATOR
Drug: administration of UIC202004

Interventions

administration of UI058DRUG

UI058 1Tab/day for 7days

Also known as: Test
UI058
administration of UIC202004DRUG

UIC202004 1Tab/day for 7days

Also known as: Reference
UIC202004

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk national university hospital

Cheongju-si, North Chungcheong, KS001, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Min Kyu Park, Dr

    Chungbuk National University Hospital

    PRINCIPAL INVESTIGATOR

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

January 5, 2022

First Posted

March 16, 2022

Study Start

February 3, 2021

Primary Completion

April 14, 2021

Study Completion

September 1, 2021

Last Updated

July 3, 2024

Record last verified: 2021-02

Locations

KR(1)