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

Korea United Pharm

Status and phase: Completed; Phase 1

Conditions: GERD

Treatments: Drug: administration of UIC202004; Drug: administration of UI058

Study type: Interventional

Funder types: Industry

Identifiers

NCT05282914

KUP-UI058-101

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

UI058

Experimental group

Treatment:

Drug: administration of UI058

UIC202004

Active Comparator group

Treatment:

Drug: administration of UIC202004