A Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of UI059 and UIC202201 in Healthy Subjects

NCT06141577 | Completed Phase 1

• 1 other identifier: KUP-UI059-101
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

GERD

Outcome Measures

Primary Outcomes (2)

• AUCtau,ss

  Area under the plasma concentration-time curve within a dosing interval at steady state

  Day 1: 0~24hours / Day 5, 6: 0hours / Day 7: 0~24hours

• Percent decrease from baseline in integrated gastric acidity

  Percent decrease from baseline in integrated gastric acidity for 24 hours after multiple(7th dose) administrations

  Day -1~Day 1, Day 1~Day 2, Day 7

Study Arms (2)

UI059

EXPERIMENTAL

Drug: UI059

UIC202201

ACTIVE COMPARATOR

Drug: UIC202201

Interventions

UI059 DRUG

take UI059 1cap/day for 7 days

Also known as: Test

UI059

UIC202201 DRUG

take UIC202201 1cap/day for 7 days

Also known as: Reference

UIC202201

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/m2.
• 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.

You may not qualify if:

• 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.
• QRS duration \> 120 ms.
• Showing the following results in clinical trial laboratory tests during screening:
• liver function assessment: AST, ALT, ALP, γ-GTP, and total bilirubin exceeding twice the upper limit of the normal range.
• Blood creatinine levels outside the reference range or calculated estimated glomerular filtration rate (eGFR) using the CKD-EPI formula less than 60 mL/min/1.73m2.
• History of drug abuse or individuals who have shown a positive reaction for abused substances in a urine drug test.

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Sites (1)

Chungbuk national university hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Minkyu Park, Dr

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, open-label, multiple-dose crossover phase 1 clinical

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: October 8, 2023
• Primary Completion: November 7, 2023
• Study Completion: November 15, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

KR (1)