A Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions

This study was an open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the safety and pharmacokinetics of UI087 compared to coadministration of UIC202506, UIC202507 and UIC202508 in healthy adult volunteers under fasting conditions

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus (Type 2)
• Intervention / Treatment: Drug: Administration of UI087; Drug: Administration of UIC202506, UIC202507, UIC202508

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: SEUNG HYUN KANG, Ph.D.; Phone Number: +82 070-4665-9490; Email: juspa@newyjh.com

Study Locations

• South Korea
  • Gwanak-gu
    • Seoul, Gwanak-gu, South Korea, 08779
      • H Plus Yangji Hospital
      • Contact: SEUNG HYUN KANG, Ph.D.; Phone Number: +82 070-4665-9490; Email: juspa@newyjh.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects aged 19 years or older at the screening visit

• Subjects with a body weight ≥ 50 kg (≥ 45 kg for females) and a body mass index (BMI) between 18.0 and 30.0 kg/m² at the screening visit

  • BMI (kg/m²) = body weight (kg) / {height (m)}²
• Subjects without clinically significant congenital or chronic diseases and without pathological symptoms or findings based on medical examination at the screening visit
• Subjects deemed eligible for participation based on diagnostic tests (hematology, blood chemistry, serology, urinalysis, etc.) and ECG, as determined by the investigator (or delegated sub-investigator) according to the characteristics of the investigational product

• Subjects who agree to use medically acceptable contraception* (excluding hormonal methods) from the first dose until 7 weeks after the last dose of the investigational product, to prevent pregnancy for themselves or their spouse/partner, and who agree not to donate sperm or ova

  • Medically acceptable contraception: Use of intrauterine devices, vasectomy, tubal ligation, and/or barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or the use of spermicide in combination with at least two barrier methods
• Subjects who voluntarily sign the informed consent form after receiving and fully understanding sufficient explanation regarding the purpose, procedures, characteristics of the investigational product, and expected adverse events of the clinical trial

Exclusion Criteria:

• Subjects with clinically significant diseases or a history of diseases involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric/neurological, musculoskeletal, immune, ENT, dermatologic, or ophthalmologic systems
• Subjects with a history of gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect drug absorption, or with gastrointestinal diseases
• Subjects who have taken enzyme-inducing or inhibiting drugs (e.g., barbiturates) within 1 month prior to the first dose, or medications that may affect the clinical trial within 10 days prior to the first dose (Participation may be allowed depending on pharmacokinetic/pharmacodynamic properties such as interactions and half- life)
• Subjects who have participated in another clinical trial or bioequivalence study and received an investigational product within 6 months prior to the first dose
• Subjects who have donated whole blood within 8 weeks, donated blood components within 2 weeks, or received a transfusion within 4 weeks prior to the first dose

• Subjects meeting the following conditions within 1 month prior to the first dose:

  • Alcohol consumption exceeding an average of 21 drinks/week for males

  • Alcohol consumption exceeding an average of 14 drinks/week for females

    (1 drink = 50 mL of soju, 30 mL of spirits, or 250 mL of beer)

  • Smoking more than an average of 20 cigarettes per day

• Subjects who meet the following:

  • Hypersensitivity to the active ingredient, excipients of the investigational product, or a drug in the same class as the investigational product
  • Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

• Subjects with the following conditions:

  • Type 1 diabetes mellitus, lactic acidosis, or acute/chronic metabolic acidosis including diabetic ketoacidosis (with or without coma), or a history of ketoacidosis
  • Moderate (stage 3b) or severe renal impairment (GFR < 45 mL/min/1.73 m²), or acute conditions that may affect renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, or sepsis
  • Acute or unstable heart failure
  • Patients undergoing intravascular iodinated contrast imaging (e.g., intravenous urography, cholangiography, angiography, contrast-enhanced CT, etc.)
  • Diabetic pre-coma
  • Severe infections or severe traumatic systemic disorders
  • Patients scheduled for surgery
  • Patients with malnutrition, starvation, debility, hypopituitarism, or adrenal insufficiency
  • Patients with acute or chronic conditions that may cause tissue hypoxia (e.g., hepatic impairment, respiratory failure, acute myocardial infarction, shock)
  • Patients with excessive alcohol intake or gastrointestinal disorders such as dehydration, diarrhea, or vomiting
• Subjects deemed unsuitable for participation by the investigator (or delegated sub-investigator) for any other reason not specified above
• Female subjects who are pregnant, suspected to be pregnant, or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UI087; Test	Drug: Administration of UI087; 1 tablet, once a day (Test)
Active Comparator: UIC202506, UIC202507, UIC202508; Reference	Drug: Administration of UIC202506, UIC202507, UIC202508; 1 tablet, once a day (Reference)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt	Evaluation PK after single dose	0 to 72 hours
Cmax	Evaluation PK after single dose	0 to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC∞	Evaluation PK after single dose	0 to 72 hours
Tmax	Evaluation PK after single dose	0 to 72 hours
t1/2	Evaluation PK after single dose	0 to 72 hours
λz	Evaluation PK after single dose	0 to 72 hours

Collaborators and Investigators

• Sponsor: Korea United Pharm. Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 5, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: KUP-UI087-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No