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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1
Chungbuk national university hospital
Cheongju-si, North Chungcheong, South Korea, KS001