Status:

COMPLETED

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

Lead Sponsor:

Korea United Pharm. Inc.

Conditions:

GERD

Eligibility:

All Genders

19-55 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 3 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2021

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT05282914

Start Date

February 3 2021

End Date

September 1 2021

Last Update

July 3 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Chungbuk national university hospital

Cheongju-si, North Chungcheong, South Korea, KS001