Study to Evaluate the Safety and the Pharmacokinetics of "UI111" and "UIC202006" Under Fed Conditions

NCT07691268 | Completed Phase 1

• 1 other identifier: KUP-UI111-101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 study to evaluate the safety and the pharmacokinetics of "UI111" and "UIC202006" in healthy adult volunteers under fed state conditions \- Open-label, randomized, single-dose, 2-sequence, 4-period, crossover design

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• AUCt

  0 to 12hours(Active ingredient A), 0 to 72hours(Active ingredient B)

• Cmax

  0 to 12hours(Active ingredient A), 0 to 72hours(Active ingredient B)

Study Arms (2)

UI111

EXPERIMENTAL

Test

Drug: Administration of UI111

UIC202006

ACTIVE COMPARATOR

Reference

Drug: Administration of UIC202006

Interventions

Administration of UI111 DRUG

1cap, once a day

UI111

Administration of UIC202006 DRUG

1cap, once a day

UIC202006

Eligibility Criteria

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

You may qualify if:

• Subjects who are at least 19 years of age at the time of the screening visit.
• Subjects who weigh at least 50 kg (at least 45 kg for females) and have a body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, at the time of the screening visit. ☞ BMI (kg/m²) = body weight (kg) / \[height (m)\]²
• Subjects who have no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on the medical examination at the time of the screening visit.
• Subjects who are determined to be eligible for participation in the study by the Principal Investigator (or a delegated sub-investigator) based on the results of diagnostic assessments, including hematology, blood chemistry, serology, urinalysis, electrocardiogram (ECG), and any other evaluations performed according to the characteristics of the investigational product.
• Subjects who agree that they and/or their spouse or partner will use medically acceptable contraceptive methods (excluding hormonal contraceptives) from the first administration of the investigational product until 7 days after the last administration of the investigational product to prevent pregnancy, and who agree not to donate sperm or ova during this period.\*
• Medically acceptable contraceptive methods include an intrauterine device (IUD), vasectomy, tubal ligation, or the combined use of barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, or contraceptive sponge). If spermicide is used, it must be combined with at least two barrier methods.
• Subjects who have received and understood a full explanation of the purpose and procedures of the study, the characteristics of the investigational product, and the anticipated adverse events, and who voluntarily provide written informed consent prior to participation in the study.

You may not qualify if:

• Subjects who have a current or past history of clinically significant diseases involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric, neurological, musculoskeletal, immune, otorhinolaryngological (ear, nose, and throat), dermatologic, or ophthalmologic systems.
• Subjects with a history of gastrointestinal surgery that may affect drug absorption (except for uncomplicated appendectomy or hernia repair), or with current gastrointestinal diseases that may affect drug absorption.
• Subjects who have taken medications known to induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 1 month prior to the first administration of the investigational product, or any medication that may interfere with the conduct of this study within 10 days prior to the first administration of the investigational product. However, participation may be permitted after consideration of the pharmacokinetic and pharmacodynamic characteristics of the medication, including its potential interaction with the investigational product and elimination 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 administration of the investigational product in this study.
• Subjects who have donated whole blood within 8 weeks, donated blood components (e.g., platelet or plasma donation) within 2 weeks, or received a blood transfusion within 4 weeks prior to the first administration of the investigational product.
• Subjects who, within 1 month prior to the first administration of the investigational product, meet any of the following criteria:
• For males: average alcohol consumption exceeding 21 standard drinks per week. For females: average alcohol consumption exceeding 14 standard drinks per week. (One standard 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 any of the following criteria: Known hypersensitivity to the investigational product or any of its components. Hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• \- Subjects with any of the following conditions: Severe hepatic impairment (e.g., biliary cirrhosis, active liver disease, or persistent unexplained elevations of transaminases exceeding 3 × the upper limit of normal \[ULN\]).
• Moderate to severe renal impairment (estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73 m²).
• A history of photoallergic or phototoxic reactions during treatment with fibrates or ketoprofen.
• Gallbladder disease. Acute or chronic pancreatitis associated with hypertriglyceridemia. Myopathy; a history of rhabdomyolysis or myopathy associated with statins or fibrates; or a history of creatine phosphokinase (CPK) elevations ≥5 × ULN during previous statin therapy.
• Interstitial lung disease. A history of pulmonary embolism. Severe myasthenia gravis or ocular myasthenia.
• Female subjects who are pregnant, suspected to be pregnant, or breastfeeding.

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Sites (1)

H plus Yangji Hospital

Seoul, Gwanak-gu 08779, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: June 25, 2026
• First Posted: July 8, 2026
• Study Start: February 13, 2025
• Primary Completion: March 10, 2025
• Study Completion: March 26, 2025
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

KR (1)