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Completed

NCT Number: NCT05282914

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

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

Completed

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk national university hospital

Cheongju-si, North Chungcheong, KS001, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

administration of UI058

Drug

UI058 1Tab/day for 7days

Other names: Test

administration of UIC202004

Drug

UIC202004 1Tab/day for 7days

Other names: Reference

Primary outcomes

  1. AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state

    Time frame: Day 7, 0~24hours

    evaluation PK for Rabeprazole after multiple dose

  2. percent change from baseline in integrated gastric acidity for 24-hour interval after 7th dose

    Time frame: baseline versus multiple dose during 7days

    evaluation PD for ambulatory 24hour pH monitor

Sponsors and collaborators

Lead sponsor

Korea United Pharm. Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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