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Can two experimental drugs be taken together safely? a trial seeks answers

NCT ID NCT07735052

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial investigates whether two experimental drugs, UIC202304 and UIC202305, can be taken together without harmful interactions. Healthy volunteers aged 19 to 55 will take one or both drugs in sequence, and researchers will measure how the drugs move through the body and any side effects. The goal is to understand the safety and proper dosing for potential future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
two experimental drugs called UIC202304 and UIC202305
What this could lead to
If successful, this study could help determine safe dosing for future trials combining these drugs.
What could go wrong
This is an early-phase trial in healthy volunteers, so results may not predict effects in patients. Drug interactions could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

40 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy adult volunteers aged 19 years or older and younger than 55 years at the time of screening. 2. 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. 3. Participants with no congenital or chronic diseases and no pathological symptoms or findings based on medical examination. 4. 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. 5. 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. 6. 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. 7. 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. Exclusion Criteria: 1\. Medical History 1. 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. 2. Participants who are vulnerable to dehydration due to inadequate oral intake or who show clinically significant signs of dehydration. 3. 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. 4. Participants with hereditary angioedema or a history of angioedema during treatment with angiotensin-converting enzyme, ACE, inhibitors or angiotensin II receptor blockers. 5. 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. 6. Participants who have had a clinically significant disease within 30 days prior to the first administration of the investigational product. 2\. Clinical Laboratory Tests and Examinations 1. 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. 2. Participants with positive results for serologic tests, including hepatitis B, hepatitis C, syphilis, or human immunodeficiency virus, HIV. 3. Participants with serum AST, ALT, or total bilirubin levels greater than 1.5 times the upper limit of normal, ULN. 4. Participants with glomerular filtration rate, GFR, calculated using the Cockcroft-Gault formula, of \<60 mL/min. 5. Participants with creatine phosphokinase, CPK, levels increased to 5 times or more the upper limit of normal, ULN. 6. Participants with clinically significant findings on 12-lead electrocardiogram, ECG, or associated physical abnormalities or symptoms. 7. Participants who are judged by the investigator to be unsuitable for study participation based on physical examination or other findings. 3\. Allergy and Drug Abuse 1. Participants with genetic problems such as intolerance to the investigational product. 2. Participants with a history of drug abuse or a positive result for drugs of abuse in a drug screening test. 3. Participants with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 4\. Prohibited Concomitant Medications and Diet 1. Participants who have participated in another clinical trial within 180 days prior to the first administration of the investigational product. 2. Participants who have taken drugs that induce or inhibit drug metabolism, including CYP3A4 inducers or inhibitors, or drugs that inhibit drug transporters, including glecaprevir and pibrentasvir, within 28 days prior to the first administration of the investigational product. 3. Participants who have taken herbal medicines within 28 days, prescription drugs within 14 days, or over-the-counter drugs within 7 days prior to the first administration of the investigational product. However, participants may be allowed to participate in the clinical trial if the investigator determines that other conditions are appropriate. 4. Participants who have consumed grapefruit or grapefruit-containing foods within 7 days prior to the first administration of the investigational product, or who are unable to refrain from consuming them during the study period. 5\. Other Criteria 1. Participants who have donated whole blood within 60 days, donated blood components within 28 days, or received a blood transfusion within 28 days prior to the first administration of the investigational product. 2. Participants who have consumed excessive alcohol within 28 days prior to the first administration of the investigational product, defined as alcohol \>30 g/day; soju \>150 mL/day, based on 20% alcohol content; beer \>750 mL/day, based on 4% alcohol content; liquor \>75 mL/day, based on 40% alcohol content; or wine \>300 mL/day, based on 10% alcohol content. 3. Participants who have smoked excessively within 28 days prior to the first administration of the investigational product, defined as \>10 cigarettes/day, or who are unable to stop smoking during the clinical trial. 4. Participants who have consumed excessive caffeine within 28 days prior to the first administration of the investigational product, defined as coffee \>5 cups/day, tea \>1,250 mL/day, or cola \>1,250 mL/day. 5. Participants who continuously consume alcohol or are unable to abstain from alcohol during the clinical trial. 6. Female participants who are pregnant or breastfeeding. 7. Participants who are judged by the investigator or study physician to be unsuitable for participation in the clinical trial for any other reason, including clinical laboratory test results, withdrawal of consent prior to admission for Period 1, or excessive tattoos.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Metro Hospital

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

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