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

Phase 1

Completed

• Conditions: GERD
• Interventions: Drug: administration of UI058; Drug: administration of UIC202004

• Registration Number: NCT05282914
• Lead Sponsor: Korea United Pharm. Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-03
• Primary Completion: 2021-04-14
• Study Completion: 2021-09-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UI058	administration of UI058	-
UIC202004	administration of UIC202004	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chungbuk national university hospital; 🇰🇷 Cheongju-si, Chungcheongbuk-do, Korea, Republic of