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

NCT07548957 | Not Yet Recruiting Phase 1

• 1 other identifier: KUP-UI087-101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus (Type 2)

Outcome Measures

Primary Outcomes (2)

• AUCt

  Evaluation PK after single dose

  0 to 72 hours

• Cmax

  Evaluation PK after single dose

  0 to 72 hours

Secondary Outcomes (4)

• AUC∞

  0 to 72 hours

• Tmax

  0 to 72 hours

• t1/2

  0 to 72 hours

• λz

  0 to 72 hours

Study Arms (2)

UI087

EXPERIMENTAL

Test

Drug: Administration of UI087

UIC202506, UIC202507, UIC202508

ACTIVE COMPARATOR

Reference

Drug: Administration of UIC202506, UIC202507, UIC202508

Interventions

Administration of UI087 DRUG

1 tablet, once a day (Test)

UI087

Administration of UIC202506, UIC202507, UIC202508 DRUG

1 tablet, once a day (Reference)

UIC202506, UIC202507, UIC202508

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Sites (1)

H plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

SEUNG HYUN KANG, Ph.D.

CONTACT

+82 070-4665-9490; juspa@newyjh.com

Study Design

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

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

KR (1)