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

Official title

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

Overview

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

Interventions

• Drug Administration of UI087
  1 tablet, once a day (Test)
• Drug Administration of UIC202506, UIC202507, UIC202508
  1 tablet, once a day (Reference)

Primary outcome measures

• AUCt [Time frame: 0 to 72 hours]
• Cmax [Time frame: 0 to 72 hours]

Secondary outcome measures (4)

• AUC∞ [Time frame: 0 to 72 hours]
• Tmax [Time frame: 0 to 72 hours]
• t1/2 [Time frame: 0 to 72 hours]
• λz [Time frame: 0 to 72 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• H plus Yangji Hospital — Seoul

Identifiers

NCT: NCT07548957 · KUP-UI087-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗