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

Sponsor

Korea United Pharm. Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05282914

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
GERD	Drug: administration of UI058 Drug: administration of UIC202004	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 3, 2021

Actual Primary Completion Date :

Apr 14, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UI058	Drug: administration of UI058 Test
Active Comparator: UIC202004	Drug: administration of UIC202004 Reference

Arm

Intervention/Treatment

Experimental: UI058

Drug: administration of UI058

Test

Active Comparator: UIC202004

Drug: administration of UIC202004

Reference

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungbuk national university hospital	Cheongju-si	Chungcheongbuk-do	Korea, Republic of	KS001

Sponsors and Collaborators

Korea United Pharm. Inc.

Investigators

Principal Investigator: Min Kyu Park, Dr, Chungbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Korea United Pharm. Inc.

ClinicalTrials.gov Identifier:

NCT05282914

Other Study ID Numbers:

KUP-UI058-101

First Posted:

Mar 16, 2022

Last Update Posted:

Mar 16, 2022

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Mar 16, 2022