A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Study to Evaluate the Pharmacokinetic Interaction and the Safety of UIC202502 and UIC202505 in Healthy Adult Volunteers

NCT07162441 | Recruiting Phase 1

• 1 other identifier: KUP-UI113-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is open-label, multiple-dose, two-intervention group, single-sequence, crossover design to compare the safety and pharmacokinetics of UIC202502 and UIC202505 when administered alone or in combination.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• AUCτ

  Evaluation PK

  0 to 24hr

• Cmax,ss

  Evaluation PK

  0 to 24hr

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: treatment A; Drug: treatment C

Arm B

EXPERIMENTAL

Drug: treatment B; Drug: treatment C

Interventions

treatment A DRUG

UIC202502 1 Tab/day for 7 days

Arm A

treatment B DRUG

UIC202505 1 Tab/day for 7 days

Arm B

treatment C DRUG

UIC202502+UIC202505 2 Tab/day for 7 days

Arm A; Arm B

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 time of screening.
• Subjects with a body weight greater than 50 kg (≥45 kg for females) and a body mass index (BMI) between 18.0 and 30.0 kg/m² at screening.
• (BMI (kg/m²) = weight (kg) / height (m)²)
• Subjects with no clinically significant congenital or chronic diseases, pathological symptoms or findings at screening.
• Subjects determined by the principal investigator to be suitable for diagnostic procedures and electrocardiogram assessments
• Subjects who agree to use an effective method of contraception (excluding hormonal agents) recognized as appropriate in clinical trials from the first administration of the investigational drug until 14 days after the last administration, together with their spouse or partner.
• Subjects who have provided written informed consent after receiving a full explanation and demonstrating an understanding of the purpose, procedures, and characteristics of this clinical trial and the investigational drug.

You may not qualify if:

• Subjects with clinically significant diseases or a history of conditions involving the digestive, cardiovascular, endocrine, respiratory, hematologic/oncologic infectious, renal/genitourinary, psychiatric/neurologic, musculoskeletal, immune, otorhinolaryngologic, dermatologic, or ophthalmologic systems.
• Subjects with a history of gastrointestinal surgery (excluding simple appendectomy or hernia repair) or gastrointestinal disease that may affect drug absorption.
• Subjects who have taken drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 1 month before the first dose, or drugs that may interfere with this clinical trial within 10 days before the first dose
• Subjects who have participated in another clinical trial or bioequivalence study and received an investigational drug within 6 months before the first administration.
• Subjects who have donated whole blood or blood components within 2 weeks, or received a blood transfusion within 4 weeks before the first administration.
• Subjects who meet any of the following criteria within 1 month before the first dose:
• Average alcohol consumption exceeding 21 drinks/week for men
• Average alcohol consumption exceeding 14 drinks/week for women
• (1 drink = 50 mL soju, 30 mL liquor, or 250 mL beer)
• Smoking more than 20 cigarettes/day on average
• Female subjects who are pregnant, suspected of being pregnant, or lactating

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Sites (1)

H plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

RECRUITING

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start: August 12, 2025
• Primary Completion: September 30, 2025
• Study Completion: March 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

KR (1)