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

Last updated: August 31, 2025
Sponsor: Korea United Pharm. Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Dyslipidemia

Treatment

treatment C

treatment A

treatment B

Clinical Study ID

NCT07162441
KUP-UI113-101
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 massindex (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, pathologicalsymptoms or findings at screening.

  • Subjects determined by the principal investigator to be suitable for diagnosticprocedures and electrocardiogram assessments

  • Subjects who agree to use an effective method of contraception (excluding hormonalagents) recognized as appropriate in clinical trials from the first administrationof the investigational drug until 14 days after the last administration, togetherwith their spouse or partner.

  • Subjects who have provided written informed consent after receiving a fullexplanation and demonstrating an understanding of the purpose, procedures, andcharacteristics of this clinical trial and the investigational drug.

Exclusion

Exclusion Criteria:

  • Subjects with clinically significant diseases or a history of conditions involvingthe digestive, cardiovascular, endocrine, respiratory, hematologic/oncologicinfectious, renal/genitourinary, psychiatric/neurologic, musculoskeletal, immune,otorhinolaryngologic, dermatologic, or ophthalmologic systems.

  • Subjects with a history of gastrointestinal surgery (excluding simple appendectomyor 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 mayinterfere with this clinical trial within 10 days before the first dose

  • Subjects who have participated in another clinical trial or bioequivalence study andreceived an investigational drug within 6 months before the first administration.

  • Subjects who have donated whole blood or blood components within 2 weeks, orreceived a blood transfusion within 4 weeks before the first administration.

  • Subjects who meet any of the following criteria within 1 month before the firstdose:

  • 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 inthis clinical trial for any reason other than the above selection or exclusioncriteria.

  • Female subjects who are pregnant, suspected of being pregnant, or lactating

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: treatment C
Phase: 1
Study Start date:
August 12, 2025
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • H plus Yangji Hospital

    Seoul 1835848, Gwanak-gu 08779
    South Korea

    Active - Recruiting

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