Actively Recruiting
A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Study to Evaluate the Pharmacokinetic Interaction and Safety of UIC202502 and UIC202505 in Healthy Adults
Led by Korea United Pharm. Inc. · Updated on 2025-09-09
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and how the body processes two drugs, UIC202502 and UIC202505, in healthy adult volunteers. The study is designed as an open-label, multiple-dose, two-intervention group, single-sequence crossover trial. This means participants will receive different treatments in a set order to compare their effects directly. Participants will take UIC202502 alone at one tablet per day for seven days, UIC202505 alone at one tablet per day for seven days, and then both drugs together as two tablets per day for seven days. This study includes two experimental arms and compares these treatments to observe any interactions between the drugs. During the study, participants will be closely monitored for safety and how their bodies absorb and process the drugs by measuring drug levels over 24 hours, including peak concentrations. Health assessments, diagnostic procedures, and electrocardiograms will be conducted. The study is expected to run until March 2026, with healthy adults participating throughout the treatment periods and assessments.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Subjects with no clinically significant congenital or chronic diseases, pathological symptoms, or findings at screening.
- Subjects deemed suitable for diagnostic procedures and electrocardiogram assessments by the principal investigator.
- Subjects who agree to use an effective method of contraception (excluding hormonal agents) recognized as appropriate in clinical trials from the first administration until 14 days after the last dose, along with their spouse or partner.
- Subjects who have provided written informed consent after understanding the full purpose, procedures, and characteristics of the trial and investigational drugs.
You will not qualify if you...
- Subjects with clinically significant diseases or a history of conditions involving 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 (except 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 within 1 month before first dose or drugs that may interfere within 10 days before first dose.
- Subjects who participated in another clinical trial and received an investigational drug within 6 months before first administration.
- Subjects who donated whole blood or components within 2 weeks or had blood transfusion within 4 weeks before first dose.
- Subjects with average alcohol consumption exceeding 21 drinks/week for men or 14 drinks/week for women within 1 month before first dose.
- Subjects smoking more than 20 cigarettes/day on average.
- Subjects judged unsuitable by the principal investigator for any other reason.
- Female subjects who are pregnant, suspected pregnant, or lactating.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Three treatment periods of 7 days each with washout periods in between
Participants receive multiple dosing of study drugs UIC202502, UIC202505, and their combination in a crossover design.
Multiple visits for dosing and assessments during each 7-day treatment period
Trial Site Locations
Total: 1 location
1
H plus Yangji Hospital
Seoul, Gwanak-gu, South Korea, 08779
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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