A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Study to Evaluate the Pharmacok… (NCT07162441) | Clinical Trial Compass
RecruitingPhase 1
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
South Korea50 participantsStarted 2025-08-12
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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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 …