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A Study to Compare PK, PD and Safety of UI058 and UIC202004 in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT05282914•Korea United Pharm. Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

19 - 55 years

Sex

ALL

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

Locations (1)

Chungbuk national university hospital

Cheongju-si, North Chungcheong, South Korea

Key Dates

Start Date

February 3, 2021

Primary Completion Date

April 14, 2021

Completion Date

September 1, 2021

Last Updated

July 3, 2024

Enrollment

ACTUAL participants

Conditions

GERD

Interventions

administration of UI058

DRUG

administration of UIC202004

DRUG

Alginate vs Sucralfate for GERD Symptomatic Relief

NCT07310927

GERD

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RECRUITINGNA

A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

NCT06953986

GERD

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RECRUITINGPHASE4

Famotidine and Antacids for Treatment of Dyspepsia

NCT06241183

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Alginate vs Sucralfate for GERD Symptomatic Relief

A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

Famotidine and Antacids for Treatment of Dyspepsia

Stretta Versus Conservative Treatment

Gracie Diet for Gastroesophageal Reflux Disease

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair