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

ConditionDyslipidemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorKorea United Pharm. Inc.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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 determined by the principal investigator to be suitable for diagnostic procedures and electrocardiogram assessments

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • treatment A

    Drug

    UIC202502 1 Tab/day for 7 days

  • treatment B

    Drug

    UIC202505 1 Tab/day for 7 days

  • treatment C

    Drug

    UIC202502+UIC202505 2 Tab/day for 7 days

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

AUCτ

Evaluation PK

Time frame
0 to 24hr
2

Cmax,ss

Evaluation PK

Time frame
0 to 24hr

Secondary outcomes

Other outcomes

Sponsors and contacts

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