Comparing safety and how the body handles UIC202502 and UIC202505 in healthy adults.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label, multiple-dose, two-intervention-group, single-sequence crossover trial enrolls healthy adult volunteers to compare the pharmacokinetics and safety of UIC202502 and UIC202505 when administered alone or in combination. Participants receive scheduled doses of each investigational product with within-subject crossover and serial blood sampling to measure drug concentrations and timing. Safety monitoring includes clinical exams and electrocardiograms alongside laboratory testing. The study is sponsored by Korea United Pharm. Inc. and conducted at H plus Yangji Hospital in Seoul.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Subjects judged by the principal investigator to be unsuitable for participation in this clinical trial for any reason other than the above selection or exclusion criteria.
* Female subjects who are pregnant, suspected of being pregnant, or lactating

Where it's running

• H plus Yangji Hospital
  Seoul, Gwanak-gu, South Korea Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.