Diabetes Mellitus (Type 2)Phase 1NCT07548957
A Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions
A Phase 1 study testing Administration of UI087 and Administration of UIC202506, UIC202507, UIC202508 in people with Diabetes Mellitus (Type 2), run by Korea United Pharm. Inc. at 1 site in South Korea.
Trial summary
This study was an open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the safety and pharmacokinetics of UI087 compared to coadministration of UIC202506, UIC202507 and UIC202508 in healthy adult volunteers under fasting conditions Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus (Type 2)
- What is being tested?
- Administration of UI087 and Administration of UIC202506, UIC202507, UIC202508
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2026to Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 19 years or older at the screening visit
- Subjects with a body weight ≥ 50 kg (≥ 45 kg for females) and a body mass index (BMI) between 18.0 and 30.0 kg/m² at the screening visit
- BMI (kg/m²) = body weight (kg) / {height (m)}²
- Subjects without clinically significant congenital or chronic diseases and without pathological symptoms or findings based on medical examination at the screening visit
- Subjects deemed eligible for participation based on diagnostic tests (hematology, blood chemistry, serology, urinalysis, etc.) and ECG, as determined by the investigator (or delegated sub-investigator) according to the characteristics of the investigational product
- Subjects who agree to use medically acceptable contraception* (excluding hormonal methods) from the first dose until 7 weeks after the last dose of the investigational product, to prevent pregnancy for themselves or their spouse/partner, and who agree not to donate sperm or ova
- Medically acceptable contraception: Use of intrauterine devices, vasectomy, tubal ligation, and/or barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or the use of spermicide in combination with at least two barrier methods
- Subjects who voluntarily sign the informed consent form after receiving and fully understanding sufficient explanation regarding the purpose, procedures, characteristics of the investigational product, and expected adverse events of the clinical trial
Who cannot join
- Subjects with clinically significant diseases or a history of diseases involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric/neurological, musculoskeletal, immune, ENT, dermatologic, or ophthalmologic systems
- Subjects with a history of gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect drug absorption, or with gastrointestinal diseases
- Subjects who have taken enzyme-inducing or inhibiting drugs (e.g., barbiturates) within 1 month prior to the first dose, or medications that may affect the clinical trial within 10 days prior to the first dose (Participation may be allowed depending on pharmacokinetic/pharmacodynamic properties such as interactions and 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 dose
- Subjects who have donated whole blood within 8 weeks, donated blood components within 2 weeks, or received a transfusion within 4 weeks prior to the first dose
- Subjects meeting the following conditions within 1 month prior to the first dose:
Show all 26Show fewer
- Alcohol consumption exceeding an average of 21 drinks/week for males
- Alcohol consumption exceeding an average of 14 drinks/week for females
- (1 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 the following:
- Hypersensitivity to the active ingredient, excipients of the investigational product, or a drug in the same class as the investigational product
- Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Subjects with the following conditions:
- Type 1 diabetes mellitus, lactic acidosis, or acute/chronic metabolic acidosis including diabetic ketoacidosis (with or without coma), or a history of ketoacidosis
- Moderate (stage 3b) or severe renal impairment (GFR < 45 mL/min/1.73 m²), or acute conditions that may affect renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, or sepsis
- Acute or unstable heart failure
- Patients undergoing intravascular iodinated contrast imaging (e.g., intravenous urography, cholangiography, angiography, contrast-enhanced CT, etc.)
- Diabetic pre-coma
- Severe infections or severe traumatic systemic disorders
- Patients scheduled for surgery
- Patients with malnutrition, starvation, debility, hypopituitarism, or adrenal insufficiency
- Patients with acute or chronic conditions that may cause tissue hypoxia (e.g., hepatic impairment, respiratory failure, acute myocardial infarction, shock)
- Patients with excessive alcohol intake or gastrointestinal disorders such as dehydration, diarrhea, or vomiting
- Subjects deemed unsuitable for participation by the investigator (or delegated sub-investigator) for any other reason not specified above
- 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
H plus Yangji Hospital
Seoul, Gwanak-gu, 08779
SEUNG HYUN KANG, Ph.D., +82 070-4665-9490, juspa@newyjh.com
About this study
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions
This study was an open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the safety and pharmacokinetics of UI087 compared to coadministration of UIC202506, UIC202507 and UIC202508 in healthy adult volunteers under fasting conditions
- Conditions
- Diabetes Mellitus (Type 2)
- Being tested
- Administration of UI087, Administration of UIC202506, UIC202507, UIC202508
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of UI087Drug
1 tablet, once a day (Test)
Administration of UIC202506, UIC202507, UIC202508Drug
1 tablet, once a day (Reference)
| Study group | Role | What they receive |
|---|---|---|
| UI087 | Experimental | Test Receives: Drug: Administration of UI087 |
| UIC202506, UIC202507, UIC202508 | Active comparator | Reference Receives: Drug: Administration of UIC202506, UIC202507, UIC202508 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Evaluation PK after single dose
Measured: 0 to 72 hours
Cmax
Evaluation PK after single dose
Measured: 0 to 72 hours
Secondary outcomes (4)
AUC∞
Evaluation PK after single dose
Measured: 0 to 72 hours
Tmax
Evaluation PK after single dose
Measured: 0 to 72 hours
t1/2
Evaluation PK after single dose
Measured: 0 to 72 hours
λz
Evaluation PK after single dose
Measured: 0 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus (Type 2)Studies 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 (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
- NCT07548957
- Sponsor's protocol ID
- KUP-UI087-101
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 23 Apr 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT07548957
- Acronym / sponsor ID
- KUP-UI087-101
- Conditions
- Diabetes Mellitus (Type 2)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Apr 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.
This study was an open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the safety and pharmacokinetics of UI087 compared to coadministration of UIC202506, UIC202507 and UIC202508 in healthy adult volunteers under fasting conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI087 | Experimental | Drug: Administration of UI087Test |
| UIC202506, UIC202507, UIC202508 | Active comparator | Drug: Administration of UIC202506, UIC202507, UIC202508Reference |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects aged 19 years or older at the screening visit
- Subjects with a body weight ≥ 50 kg (≥ 45 kg for females) and a body mass index (BMI) between 18.0 and 30.0 kg/m² at the screening visit
- Subjects without clinically significant congenital or chronic diseases and without pathological symptoms or findings based on medical examination at the screening visit
- Subjects deemed eligible for participation based on diagnostic tests (hematology, blood chemistry, serology, urinalysis, etc.) and ECG, as determined by the investigator (or delegated sub-investigator) according to the characteristics of the investigational product
- Subjects who agree to use medically acceptable contraception* (excluding hormonal methods) from the first dose until 7 weeks after the last dose of the investigational product, to prevent pregnancy for themselves or their spouse/partner, and who agree not to donate sperm or ova
Key exclusion criteria (26 listed)
- Subjects with clinically significant diseases or a history of diseases involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric/neurological, musculoskeletal, immune, ENT, dermatologic, or ophthalmologic systems
- Subjects with a history of gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect drug absorption, or with gastrointestinal diseases
- Subjects who have taken enzyme-inducing or inhibiting drugs (e.g., barbiturates) within 1 month prior to the first dose, or medications that may affect the clinical trial within 10 days prior to the first dose (Participation may be allowed depending on pharmacokinetic/pharmacodynamic properties such as interactions and 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 dose
- Subjects who have donated whole blood within 8 weeks, donated blood components within 2 weeks, or received a transfusion within 4 weeks prior to the first dose
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 UI0871 tablet, once a day (Test) | Drug | UI087 |
| Administration of UIC202506, UIC202507, UIC2025081 tablet, once a day (Reference) | Drug | UIC202506, UIC202507, UIC202508 |
Primary outcome
AUCt
Time frame: 0 to 72 hours
Evaluation PK after single dose
Cmax
Time frame: 0 to 72 hours
Evaluation PK after single dose
4 secondary outcomes
AUC∞
Time frame: 0 to 72 hours
Tmax
Time frame: 0 to 72 hours
t1/2
Time frame: 0 to 72 hours
λz
Time frame: 0 to 72 hours
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 23 Apr 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 Administration of UI087 and Administration of UIC202506, UIC202507, UIC202508 in people with Diabetes Mellitus (Type 2), 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: opening soon, as of the sponsor's last update on 23 Apr 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?
Contact SEUNG HYUN KANG, Ph.D. (+82 070-4665-9490, juspa@newyjh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt (time frame: 0 to 72 hours). 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 23 Apr 2026.