HealhtyPhase 1NCT07735052
Drug-drug Interaction Study Between UIC202304, and UIC202305
A Phase 1 study testing UIC202304 and co-administration of UIC202304 and UIC202305 and UIC202305 and co-administration of UIC202304 and UIC202305 in people with Healhty, run by Korea United Pharm. Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healhty
- What is being tested?
- UIC202304 and co-administration of UIC202304 and UIC202305 and UIC202305 and co-administration of UIC202304 and UIC202305
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2023to 9 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 1. 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.
Show all 32Show fewer
- 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
- 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.
- 3. Allergy and Drug Abuse
- Participants with genetic problems such as intolerance to the investigational product.
- Participants with a history of drug abuse or a positive result for drugs of abuse in a drug screening test.
- Participants with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- 4. Prohibited Concomitant Medications and Diet
- Participants who have participated in another clinical trial within 180 days prior to the first administration of the investigational product.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- Participants who continuously consume alcohol or are unable to abstain from alcohol during the clinical trial.
- Female participants who are pregnant or breastfeeding.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Being tested
- UIC202304 and co-administration of UIC202304 and UIC202305, UIC202305 and co-administration of UIC202304 and UIC202305
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UIC202304 and co-administration of UIC202304 and UIC202305Drug
- UIC202304 1 Tab/day for 9 days
- UIC202304 1 Tab/day + UIC202305 1 Tab/day for 7 days
UIC202305 and co-administration of UIC202304 and UIC202305Drug
- UIC202305 1 Tab/day for 7 days
- UIC202304 1 Tab/day + UIC202305 1 Tab/day for 9 days
| Study group | Role | What they receive |
|---|---|---|
| UIC202304 followed by coadministration With UIC202305 | Experimental | UIC202304 and co-administration of UIC202304 and UIC202305 Receives: Drug: UIC202304 and co-administration of UIC202304 and UIC202305 |
| UIC202305 followed by coadministration With UIC202304 | Experimental | UIC202305 and co-administration of UIC202304 and UIC202305 Receives: Drug: UIC202305 and co-administration of UIC202304 and UIC202305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity at Steady State (AUCss,inf) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Measured: 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)
Time to Maximum Plasma Concentration at Steady State (Tss,max) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Measured: 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)
Elimination Half-Life at Steady State (tss,1/2) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Measured: 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)
Minimum Plasma Concentration at Steady State (Css,min) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Measured: 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)
Apparent Total Body Clearance at Steady State (CLss/F) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Measured: 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 Volume of Distribution (Vd/F)
Apparent Volume of Distribution (Vd/F) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Measured: 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.
Peak-to-Trough Fluctuation at Steady State (PTF)
Peak-to-Trough Fluctuation at Steady State (PTF) will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start25 Sep 2023
- Primary completion24 Nov 2023
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-Dae Kwon, M.D.,Ph.D, Principal investigator, Metro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735052
- Sponsor's protocol ID
- KUP-UI089-101
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07735052
- Acronym / sponsor ID
- KUP-UI089-101
- Conditions
- Healhty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UIC202304 followed by coadministration With UIC202305 | Experimental | Drug: UIC202304 and co-administration of UIC202304 and UIC202305UIC202304 and co-administration of UIC202304 and UIC202305 |
| UIC202305 followed by coadministration With UIC202304 | Experimental | Drug: UIC202305 and co-administration of UIC202304 and UIC202305UIC202305 and co-administration of UIC202304 and UIC202305 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (32 listed)
- 1. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UIC202304 and co-administration of UIC202304 and UIC202305* UIC202304 1 Tab/day for 9 days * UIC202304 1 Tab/day + UIC202305 1 Tab/day for 7 days | Drug | UIC202304 followed by coadministration With UIC202305 |
| UIC202305 and co-administration of UIC202304 and UIC202305* UIC202305 1 Tab/day for 7 days * UIC202304 1 Tab/day + UIC202305 1 Tab/day for 9 days | Drug | UIC202305 followed by coadministration With UIC202304 |
Primary outcome
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss,τ)
Time frame: 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.
AUCss,τ will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
Maximum Plasma Concentration at Steady State (Css,max)
Time frame: 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.
Css,max will be determined for amlodipine, telmisartan, atorvastatin, 2-hydroxy atorvastatin, total ezetimibe, and free ezetimibe.
7 secondary outcomes
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity at Steady State (AUCss,inf)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Volume of Distribution (Vd/F)
Time frame: 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.
Peak-to-Trough Fluctuation at Steady State (PTF)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Dae Kwon, M.D.,Ph.D principal investigator
Metro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UIC202304 and co-administration of UIC202304 and UIC202305 and UIC202305 and co-administration of UIC202304 and UIC202305 in people with Healhty, run by Korea United Pharm. Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss,τ) (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.