DyslipidemiaPhase 1NCT07691268
Study to Evaluate the Safety and the Pharmacokinetics of "UI111" and "UIC202006" Under Fed Conditions
A Phase 1 study testing Administration of UI111 and Administration of UIC202006 in people with Dyslipidemia, run by Korea United Pharm. Inc. at 1 site in South Korea.
Trial summary
Phase 1 study to evaluate the safety and the pharmacokinetics of "UI111" and "UIC202006" in healthy adult volunteers under fed state conditions Open-label, randomized, single-dose, 2-sequence, 4-period, crossover design Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Administration of UI111 and Administration of UIC202006
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Feb 2025to 26 Mar 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who are at least 19 years of age at the time of the screening visit.
- Subjects who weigh at least 50 kg (at least 45 kg for females) and have a body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, at the time of 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 the medical examination at the time of the screening visit.
- Subjects who are determined to be eligible for participation in the study by the Principal Investigator (or a delegated sub-investigator) based on the results of diagnostic assessments, including hematology, blood chemistry, serology, urinalysis, electrocardiogram (ECG), and any other evaluations performed according to the characteristics of the investigational product.
- Subjects who agree that they and/or their spouse or partner will use medically acceptable contraceptive methods (excluding hormonal contraceptives) from the first administration of the investigational product until 7 days after the last administration of the investigational product to prevent pregnancy, and who agree not to donate sperm or ova during this period.*
- Medically acceptable contraceptive methods include an intrauterine device (IUD), vasectomy, tubal ligation, or the combined use of barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, or contraceptive sponge). If spermicide is used, it must be combined with at least two barrier methods.
- Subjects who have received and understood a full explanation of the purpose and procedures of the study, the characteristics of the investigational product, and the anticipated adverse events, and who voluntarily provide written informed consent prior to participation in the study.
Who cannot join
- Subjects who have a current or past history of clinically significant diseases involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric, neurological, musculoskeletal, immune, otorhinolaryngological (ear, nose, and throat), dermatologic, or ophthalmologic systems.
- Subjects with a history of gastrointestinal surgery that may affect drug absorption (except for uncomplicated appendectomy or hernia repair), or with current gastrointestinal diseases that may affect drug absorption.
- Subjects who have taken medications known to induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 1 month prior to the first administration of the investigational product, or any medication that may interfere with the conduct of this study within 10 days prior to the first administration of the investigational product. However, participation may be permitted after consideration of the pharmacokinetic and pharmacodynamic characteristics of the medication, including its potential interaction with the investigational product and elimination half-life.
- Subjects who have participated in another clinical trial or bioequivalence study and received an investigational product within 6 months prior to the first administration of the investigational product in this study.
- Subjects who have donated whole blood within 8 weeks, donated blood components (e.g., platelet or plasma donation) within 2 weeks, or received a blood transfusion within 4 weeks prior to the first administration of the investigational product.
- Subjects who, within 1 month prior to the first administration of the investigational product, meet any of the following criteria:
Show all 14Show fewer
- For males: average alcohol consumption exceeding 21 standard drinks per week. For females: average alcohol consumption exceeding 14 standard drinks per week. (One standard drink = 50 mL of soju, 30 mL of spirits, or 250 mL of beer.) Smoking more than an average of 20 cigarettes per day. - Subjects who meet any of the following criteria: Known hypersensitivity to the investigational product or any of its components. Hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Subjects with any of the following conditions: Severe hepatic impairment (e.g., biliary cirrhosis, active liver disease, or persistent unexplained elevations of transaminases exceeding 3 × the upper limit of normal [ULN]).
- Moderate to severe renal impairment (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m²).
- A history of photoallergic or phototoxic reactions during treatment with fibrates or ketoprofen.
- Gallbladder disease. Acute or chronic pancreatitis associated with hypertriglyceridemia. Myopathy; a history of rhabdomyolysis or myopathy associated with statins or fibrates; or a history of creatine phosphokinase (CPK) elevations ≥5 × ULN during previous statin therapy.
- Interstitial lung disease. A history of pulmonary embolism. Severe myasthenia gravis or ocular myasthenia.
- Subjects whom the Principal Investigator (or a delegated sub-investigator) considers unsuitable for participation in this study for any reason other than the inclusion and exclusion criteria listed above.
- Female subjects who are pregnant, suspected to be pregnant, or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of "UI111" and "UIC202006" in Healthy Adult Volunteers Under Fed State Conditions
Phase 1 study to evaluate the safety and the pharmacokinetics of "UI111" and "UIC202006" in healthy adult volunteers under fed state conditions
- Open-label, randomized, single-dose, 2-sequence, 4-period, crossover design
- Conditions
- Dyslipidemia
- Being tested
- Administration of UI111, Administration of UIC202006
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of UI111Drug
1cap, once a day
Administration of UIC202006Drug
1cap, once a day
| Study group | Role | What they receive |
|---|---|---|
| UI111 | Experimental | Test Receives: Drug: Administration of UI111 |
| UIC202006 | Active comparator | Reference Receives: Drug: Administration of UIC202006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Measured: 0 to 12hours(Active ingredient A), 0 to 72hours(Active ingredient B)
Cmax
Measured: 0 to 12hours(Active ingredient A), 0 to 72hours(Active ingredient B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start13 Feb 2025
- Primary completion10 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- 44 participants (actual)
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
- NCT07691268
- Sponsor's protocol ID
- KUP-UI111-101
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 8 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of "UI111" and "UIC202006" in Healthy Adult Volunteers Under Fed State Conditions
- ClinicalTrials.gov ID
- NCT07691268
- Acronym / sponsor ID
- KUP-UI111-101
- Conditions
- Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 8 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.
Phase 1 study to evaluate the safety and the pharmacokinetics of "UI111" and "UIC202006" in healthy adult volunteers under fed state conditions
- Open-label, randomized, single-dose, 2-sequence, 4-period, crossover design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI111 | Experimental | Drug: Administration of UI111Test |
| UIC202006 | Active comparator | Drug: Administration of UIC202006Reference |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are at least 19 years of age at the time of the screening visit.
- Subjects who weigh at least 50 kg (at least 45 kg for females) and have a body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, at the time of 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 the medical examination at the time of the screening visit.
- Subjects who are determined to be eligible for participation in the study by the Principal Investigator (or a delegated sub-investigator) based on the results of diagnostic assessments, including hematology, blood chemistry, serology, urinalysis, electrocardiogram (ECG), and any other evaluations performed according to the characteristics of the investigational product.
- Subjects who agree that they and/or their spouse or partner will use medically acceptable contraceptive methods (excluding hormonal contraceptives) from the first administration of the investigational product until 7 days after the last administration of the investigational product to prevent pregnancy, and who agree not to donate sperm or ova during this period.*
Key exclusion criteria (14 listed)
- Subjects who have a current or past history of clinically significant diseases involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric, neurological, musculoskeletal, immune, otorhinolaryngological (ear, nose, and throat), dermatologic, or ophthalmologic systems.
- Subjects with a history of gastrointestinal surgery that may affect drug absorption (except for uncomplicated appendectomy or hernia repair), or with current gastrointestinal diseases that may affect drug absorption.
- Subjects who have taken medications known to induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 1 month prior to the first administration of the investigational product, or any medication that may interfere with the conduct of this study within 10 days prior to the first administration of the investigational product. However, participation may be permitted after consideration of the pharmacokinetic and pharmacodynamic characteristics of the medication, including its potential interaction with the investigational product and elimination half-life.
- Subjects who have participated in another clinical trial or bioequivalence study and received an investigational product within 6 months prior to the first administration of the investigational product in this study.
- Subjects who have donated whole blood within 8 weeks, donated blood components (e.g., platelet or plasma donation) within 2 weeks, or received a blood transfusion within 4 weeks prior to the first administration of the investigational product.
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 |
|---|---|---|
| Administration of UI1111cap, once a day | Drug | UI111 |
| Administration of UIC2020061cap, once a day | Drug | UIC202006 |
Primary outcome
AUCt
Time frame: 0 to 12hours(Active ingredient A), 0 to 72hours(Active ingredient B)
Cmax
Time frame: 0 to 12hours(Active ingredient A), 0 to 72hours(Active ingredient B)
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 8 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Administration of UI111 and Administration of UIC202006 in people with 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 7 inclusion and 14 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 8 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?
AUCt (time frame: 0 to 12hours(Active ingredient A), 0 to 72hours(Active ingredient B)). 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 8 Jul 2026.