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NCT05282914 Clinical Trial

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

GERD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05282914
Other study ID # KUP-UI058-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 3, 2021
Est. completion date September 1, 2021

Study information
Verified date February 2021
Source Korea United Pharm. Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date September 1, 2021
Est. primary completion date April 14, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• administration of UI058
Test
• administration of UIC202004
Reference

Locations
Country Name City State
Korea, Republic of Chungbuk national university hospital Cheongju-si Chungcheongbuk-do

Sponsors (1)
Lead Sponsor Collaborator
Korea United Pharm. Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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