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

A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics Between "UI058" and "UIC202004" in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: administration of UI058; Drug: administration of UIC202004

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chungcheongbuk-do
    • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, KS001
      • Chungbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UI058	Drug: administration of UI058; UI058 1Tab/day for 7days; Other Names: Test
Active Comparator: UIC202004	Drug: administration of UIC202004; UIC202004 1Tab/day for 7days; Other Names: Reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Korea United Pharm. Inc.
• Investigators: Principal Investigator: Min Kyu Park, Dr, Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): April 14, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: KUP-UI058-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No