HypertensionPhase 1NCT07682948
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
A Phase 1 study testing Investigational Product 1, Investigational Product 2 and Investigational Product 1 + Investigational Product 2 in people with Hypertension and Dyslipidemia, run by Korea United Pharm. Inc. at 1 site in South Korea.
Trial summary
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Investigational Product 1, Investigational Product 2 and Investigational Product 1 + Investigational Product 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2026to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged 19 years or older and less than 55 years at the screening visit.
- Subjects with a body weight of at least 50 kg (at least 45 kg for females) and a body mass index (BMI) of 18.0 kg/m² or higher and 30.0 kg/m² or lower at the screening visit.
- BMI (kg/m²) = Body weight (kg) / Height (m)²
- Subjects who have no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on medical examination at the screening visit.
- Subjects determined to be eligible for participation in the clinical trial by the Investigator (or delegated Sub-investigator) based on the evaluation results of hematology, blood chemistry, serology, urinalysis, other clinical laboratory tests, physical examination, and electrocardiogram (ECG), which are established and performed according to the characteristics of the investigational product.
- Subjects who agree that they and/or their spouse or partner will use highly effective contraception (excluding hormonal contraceptives) from the first administration of the investigational product until 14 days after the last administration to prevent pregnancy and who agree not to donate sperm or ova.
- Highly effective methods of contraception: intrauterine device (IUD), bilateral tubal occlusion, vasectomized partner, sexual abstinence.
- Subjects who have received and understood sufficient explanation regarding the purpose, procedures, characteristics of the investigational product, and anticipated adverse events of this clinical trial, and who have voluntarily signed the informed consent form.
Who cannot join
- Subjects with current or past history of clinically significant diseases involving the renal system (e.g., severe renal impairment), nervous system (e.g., cerebrovascular disease), immune system, respiratory system (e.g., bronchial asthma), urinary system, gastrointestinal system, endocrine system (e.g., congenital lipid metabolism disorders, severe diabetes mellitus), hematologic/oncologic system, cardiovascular system (e.g., severe hypertension, heart failure, coronary artery disease), reproductive system (e.g., endometrial hyperplasia, endometriosis), psychiatric disorders, or myopathy.
- Subjects with a history of gastrointestinal surgery (except simple appendectomy or hernia repair) that may affect drug absorption, or with gastrointestinal disease.
- Subjects with severe hepatic impairment, biliary obstruction, or cholestasis (this drug is excreted almost entirely via bile. Cholestasis, biliary obstructive disease, or hepatic impairment may be expected to reduce hepatic clearance.).
- Subjects with active liver disease or persistent elevation of aminotransferase levels of unknown cause.
- Subjects with hereditary angioedema or a history of angioedema during treatment with an ACE inhibitor or an angiotensin II receptor blocker.
- Subjects who have taken enzyme-inducing or enzyme-inhibiting drugs such as barbiturates within 1 month before the first administration, or who have taken medications that may interfere with this clinical trial within 10 days before the first administration (however, participation may be allowed after considering pharmacokinetic and pharmacodynamic characteristics such as interactions with the investigational product and drug half-life).
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- Subjects who have consumed grapefruit-containing foods within 7 days before the first administration or who are unable to refrain from consuming such foods during the clinical trial.
- Subjects who have participated in another clinical trial or bioequivalence study and received an investigational product within 6 months before the first administration.
- Subjects who have donated whole blood within 8 weeks before the first administration, donated blood components within 2 weeks, or received a blood transfusion within 4 weeks.
- Subjects considered unsuitable for participation based on screening assessments performed within 30 days before the first administration of the investigational product.
- AST or ALT > 1.5 × the upper limit of the normal range.
- Total bilirubin > 1.5 × the upper limit of the normal range.
- eGFR (estimated Glomerular Filtration Rate), calculated using the MDRD (Modification of Diet in Renal Disease) equation, < 60 mL/min/1.73m².
- Positive results for serologic tests (hepatitis B, hepatitis C, human immunodeficiency virus [HIV], or syphilis).
- After at least 5 minutes of rest, seated vital signs showing systolic blood pressure > 139 mmHg or < 100 mmHg, or diastolic blood pressure > 90 mmHg or < 60 mmHg.
- Subjects who meet any of the following conditions within 1 month before the first administration.
- Average alcohol consumption exceeding 21 drinks/week for males.
- Average alcohol consumption exceeding 14 drinks/week for females.
- (1 drink = 50 mL of soju, 30 mL of spirits, or 250 mL of beer.)
- Smoking more than 10 cigarettes per day on average.
- Subjects who meet any of the following conditions.
- Subjects with hypersensitivity to this drug or any of its components.
- Subjects with hereditary problems of fructose or galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Subjects whom the Investigator (or delegated Sub-investigator) considers unsuitable for participation in this clinical trial for reasons other than the above inclusion/exclusion criteria (e.g., excessive tattoos).
- Subjects with a history of drug abuse within 1 year before screening or those with a positive urine drug screening test.
- Female subjects who are pregnant, suspected to be pregnant, or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Metro Hospital
Anyang, Manan-gu, 14096
Seongdae Kwon, 031-467-9927, uro777@nate.com
About this study
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Investigational Product 1, Investigational Product 2, Investigational Product 1 + Investigational Product 2
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Product 1Drug
UIC202601 1Tab/day for 7 days
Investigational Product 2Drug
UIC202602 1Tab/day for 7 days
Investigational Product 1 + Investigational Product 2Drug
UIC202601+UIC202602 2Tab/day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Investigational Product 1; Drug: Investigational Product 1 + Investigational Product 2 |
| Arm B | Experimental | Not described Receives: Drug: Investigational Product 2; Drug: Investigational Product 1 + Investigational Product 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss
Evaluation PK
Measured: 0 to 24hr
Cmax,ss
Evaluation PK
Measured: 0 to 24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682948
- Sponsor's protocol ID
- KUP-UI133-101
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07682948
- Acronym / sponsor ID
- KUP-UI133-101
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 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-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Investigational Product 1, Drug: Investigational Product 1 + Investigational Product 2 |
| Arm B | Experimental | Drug: Investigational Product 2, Drug: Investigational Product 1 + Investigational Product 2 |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects aged 19 years or older and less than 55 years at the screening visit.
- Subjects with a body weight of at least 50 kg (at least 45 kg for females) and a body mass index (BMI) of 18.0 kg/m² or higher and 30.0 kg/m² or lower at the screening visit.
- BMI (kg/m²) = Body weight (kg) / Height (m)²
- Subjects who have no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on medical examination at the screening visit.
- Subjects determined to be eligible for participation in the clinical trial by the Investigator (or delegated Sub-investigator) based on the evaluation results of hematology, blood chemistry, serology, urinalysis, other clinical laboratory tests, physical examination, and electrocardiogram (ECG), which are established and performed according to the characteristics of the investigational product.
Key exclusion criteria (26 listed)
- Subjects with current or past history of clinically significant diseases involving the renal system (e.g., severe renal impairment), nervous system (e.g., cerebrovascular disease), immune system, respiratory system (e.g., bronchial asthma), urinary system, gastrointestinal system, endocrine system (e.g., congenital lipid metabolism disorders, severe diabetes mellitus), hematologic/oncologic system, cardiovascular system (e.g., severe hypertension, heart failure, coronary artery disease), reproductive system (e.g., endometrial hyperplasia, endometriosis), psychiatric disorders, or myopathy.
- Subjects with a history of gastrointestinal surgery (except simple appendectomy or hernia repair) that may affect drug absorption, or with gastrointestinal disease.
- Subjects with severe hepatic impairment, biliary obstruction, or cholestasis (this drug is excreted almost entirely via bile. Cholestasis, biliary obstructive disease, or hepatic impairment may be expected to reduce hepatic clearance.).
- Subjects with active liver disease or persistent elevation of aminotransferase levels of unknown cause.
- Subjects with hereditary angioedema or a history of angioedema during treatment with an ACE inhibitor or an angiotensin II receptor blocker.
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 |
|---|---|---|
| Investigational Product 1UIC202601 1Tab/day for 7 days | Drug | Arm A |
| Investigational Product 2UIC202602 1Tab/day for 7 days | Drug | Arm B |
| Investigational Product 1 + Investigational Product 2UIC202601+UIC202602 2Tab/day for 7 days | Drug | Arm A, Arm B |
Primary outcome
AUCτ,ss
Time frame: 0 to 24hr
Evaluation PK
Cmax,ss
Time frame: 0 to 24hr
Evaluation PK
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
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 Investigational Product 1, Investigational Product 2 and Investigational Product 1 + Investigational Product 2 in people with Hypertension and Dyslipidemia, 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 8 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCτ,ss (time frame: 0 to 24hr). 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 6 Jul 2026.