A Randomized, Open-label, Multiple-dose Crossover Phase 1 Clinical Trial to Compare and Evaluate the Safety, Pharmacokinetics and Pharmacodynamics Characteristics After Oral Administration of UI059 and UIC202201 in Healthy Adult Volunteers

Korea United Pharm. Inc.1 site in 1 country66 target enrollmentJuly 3, 2024

ConditionsGastro-Intestinal Disorder

InterventionsUI059 UIC202201

DrugsUI059 UIC202201

Overview

Phase: Phase 1
Intervention: UI059
Conditions: Gastro-Intestinal Disorder
Sponsor: Korea United Pharm. Inc.
Enrollment: 66
Locations: 1
Primary Endpoint: Percent decrease from baseline in integrated gastric acidity
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, open-label, multiple-dose crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers

Registry

clinicaltrials.gov

Start Date

July 3, 2024

End Date

September 21, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Korea United Pharm. Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•healthy adult volunteers aged 19 and above.
•For males, a weight of 50.0 kg or more, and for females, a weight of 45.0 kg or more, with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m
•BMI(kg/m2)=Weight(kg)/height(m)2
•No congenital or chronic diseases requiring treatment, and no pathological symptoms or findings based on internal medicine examination.
•Those who were determined to be suitable subjects for clinical trials as a result of tests such as clinical laboratory tests, vital signs, physical examination (physical examination), and 12-lead electrocardiogram
•Negative for H. pylori antibodies
•After receiving detailed explanations about the clinical trial and fully understanding, participants voluntarily decide to participate and provide written consent to adhere to the subject compliance requirements throughout the trial period.

Exclusion Criteria

•Current or past medical history of clinically significant conditions involving the liver, kidneys, nervous system, mental health, respiratory system, endocrine system, blood disorders, tumors, genitourinary system, cardiovascular system, digestive system, musculoskeletal system, etc., and in addition:
•currently receiving antiretroviral drugs (rilpivirine, atazanavir, nelfinavir)
•liver disorders
•kidney disorders
•History of gastrointestinal conditions (Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of the investigational drug.
•Pregnant (positive Urine-HCG) or lactating for female participants
•Have a history of hypersensitivity reactions (such as anaphylaxis or angioedema) or clinically significant hypersensitivity reactions to drugs, excipients, or other substances, including medications containing the active ingredients of the investigational drug, additives, and other drugs (such as aspirin, penicillin antibiotics, macrolide antibiotics).
•Have clinically significant findings on the 12-lead electrocardiogram during screening, including:
•QTc interval \> 450 ms for males or \> 470 ms for females.
•PR interval \> 200 ms.