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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05282914

Enrollment

Registered

2022-03-16

Start date

2021-02-03

Completion date

2021-09-01

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Brief summary

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

Interventions

DRUGadministration of UI058

UI058 1Tab/day for 7days

DRUGadministration of UIC202004

UIC202004 1Tab/day for 7days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026