Drug-drug Interaction Study Between UIC202304, and UIC202305

NCT07735052 | Completed Phase 1

• 1 other identifier: KUP-UI089-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, open-label, two-sequence, two-period, multiple-dose, study to evaluate pharmacokinetic drug-drug interaction, safety and tolerability of UIC202304 and UIC202305 in healthy volunteers.

Conditions

Healhty

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss,τ)

  AUCss,τ will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.

  Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.

• Maximum Plasma Concentration at Steady State (Css,max)

  Css,max will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.

  Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.

Secondary Outcomes (7)

• Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity at Steady State (AUCss,inf)

  Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.

• Time to Maximum Plasma Concentration at Steady State (Tss,max)

  Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.

• Elimination Half-Life at Steady State (tss,1/2)

  Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.

• Minimum Plasma Concentration at Steady State (Css,min)

  Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.

• Apparent Total Body Clearance at Steady State (CLss/F)

  Predose (0 hour) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 9 and 16 for UIC202304 alone and with UIC202305, and on Days 7 and 16 for UIC202305 alone and with UIC202304.

Study Arms (2)

UIC202304 followed by coadministration With UIC202305

EXPERIMENTAL

UIC202304 and co-administration of UIC202304 and UIC202305

Drug: UIC202304 and co-administration of UIC202304 and UIC202305

UIC202305 followed by coadministration With UIC202304

EXPERIMENTAL

UIC202305 and co-administration of UIC202304 and UIC202305

Drug: UIC202305 and co-administration of UIC202304 and UIC202305

Interventions

UIC202304 and co-administration of UIC202304 and UIC202305 DRUG

* UIC202304 1 Tab/day for 9 days * UIC202304 1 Tab/day + UIC202305 1 Tab/day for 7 days

UIC202304 followed by coadministration With UIC202305

UIC202305 and co-administration of UIC202304 and UIC202305 DRUG

* UIC202305 1 Tab/day for 7 days * UIC202304 1 Tab/day + UIC202305 1 Tab/day for 9 days

UIC202305 followed by coadministration With UIC202304

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers aged 19 years or older and younger than 55 years at the time of screening.
• Male participants weighing at least 50 kg and female participants weighing at least 45 kg, with a body mass index, BMI, between 18.0 and 30.0 kg/m², inclusive.
• Participants with no congenital or chronic diseases and no pathological symptoms or findings based on medical examination.
• Participants who are judged by the investigator to be eligible for the study based on medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram, ECG, performed within 4 weeks prior to the first administration of the investigational product, considering the characteristics of the investigational product.
• Participants who are able to understand and comply with the study instructions and who are available to participate for the entire duration of the clinical trial.
• Participants who agree to use contraception during the clinical trial and are able to comply with medically acceptable contraceptive methods, including a medically sterile or non-fertile condition. See Section 9.3.1 for acceptable contraceptive methods.
• Participants who voluntarily decide to participate in the clinical trial after receiving and fully understanding a detailed explanation of the study and who provide written informed consent to comply with study requirements and precautions.

You may not qualify if:

• \. Medical History
• Participants with a current or past history of clinically significant diseases involving the biliary system, including biliary obstructive disease; renal system, including severe renal impairment; hematologic or oncologic disorders; cardiovascular system, including congestive heart failure, coronary artery disease, aortic or mitral valve stenosis or related complications, arrhythmia, or renovascular hypertension; respiratory system, including asthma or chronic obstructive pulmonary disease; liver disease, including moderate or severe hepatic impairment; endocrine system, including diabetes mellitus, impaired glucose tolerance, hypothyroidism, or primary aldosteronism; gastrointestinal system; musculoskeletal system; central nervous system, including Parkinson's disease; psychiatric disorders; or malignant tumors.
• Participants who are vulnerable to dehydration due to inadequate oral intake or who show clinically significant signs of dehydration.
• Participants with a current or past history of gastrointestinal diseases that may affect drug absorption, including Crohn's disease, ulcer, gastritis, gastric spasm, gastroesophageal reflux disease, acute or chronic pancreatitis, or gastrointestinal surgery, except simple appendectomy or hernia repair.
• Participants with hereditary angioedema or a history of angioedema during treatment with angiotensin-converting enzyme, ACE, inhibitors or angiotensin II receptor blockers.
• Participants with a history of hypersensitivity or clinically significant hypersensitivity to amlodipine, telmisartan, atorvastatin, ezetimibe, drugs of similar classes, including other dihydropyridines, or other drugs, including aspirin or antibiotics.
• Participants who have had a clinically significant disease within 30 days prior to the first administration of the investigational product.
• \. Clinical Laboratory Tests and Examinations
• Participants who, after sufficient rest, show any of the following vital sign values measured in a sitting position: systolic blood pressure \>140 mmHg or \<100 mmHg, diastolic blood pressure \>90 mmHg or \<60 mmHg, or pulse rate \>100 beats/min or \<60 beats/min.
• Participants with positive results for serologic tests, including hepatitis B, hepatitis C, syphilis, or human immunodeficiency virus, HIV.
• Participants with serum AST, ALT, or total bilirubin levels greater than 1.5 times the upper limit of normal, ULN.
• Participants with glomerular filtration rate, GFR, calculated using the Cockcroft-Gault formula, of \<60 mL/min.
• Participants with creatine phosphokinase, CPK, levels increased to 5 times or more the upper limit of normal, ULN.
• Participants with clinically significant findings on 12-lead electrocardiogram, ECG, or associated physical abnormalities or symptoms.
• Participants who are judged by the investigator to be unsuitable for study participation based on physical examination or other findings.

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Sites (1)

Metro Hospital

Anyang-si, Gyeonggi-do, 14086, South Korea

Location

Study Officials

• Sung-Dae Kwon, M.D.,Ph.D

  Metro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 29, 2026
• Study Start: September 25, 2023
• Primary Completion: November 24, 2023
• Study Completion: September 9, 2024
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

KR (1)