A Phase 1 interventional study of Semaglutide (UI112) and Semaglutide (UIC202611) in Bioequivalence and Pharmacokinetics, sponsored by Korea United Pharm. Inc.. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Korea United Pharm. Inc. · Phase 1, Interventional, and Other
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This Phase 1 clinical trial aims to compare the pharmacokinetics and safety of UI112 and UIC202611 (Wegovy), two injectable products containing semaglutide, in healthy adult volunteers.
A total of 44 healthy adults will be randomly assigned to one of two treatment sequences. Each participant will receive a single 0.5 mg subcutaneous injection of UI112 and UIC202611 in separate treatment periods, with a 6-week washout period between administrations.
Blood samples will be collected at scheduled time points to measure semaglutide concentrations and compare how the two products are absorbed and eliminated from the body. Safety will also be assessed through adverse events, physical examinations, vital signs, electrocardiograms, and laboratory tests.
This is a randomized, open-label, single-dose, two-period, two-sequence crossover Phase 1 clinical trial conducted in healthy adult volunteers.
Participants will be randomly assigned to one of two treatment sequences:
Each participant will receive a single 0.5 mg dose of semaglutide by subcutaneous injection into the abdomen during each treatment period. A 6-week washout period will separate the two administrations.
Blood samples for pharmacokinetic analysis will be collected before dosing and at scheduled intervals up to 504 hours (Day 22) after each administration. The primary pharmacokinetic endpoints are AUCt and Cmax. Secondary pharmacokinetic endpoints include AUC168h, AUCinf, CL/F, Vz/F, Tmax, and t1/2.
Pharmacokinetic equivalence will be evaluated using the geometric mean ratios of AUCt and Cmax between the test and reference products and their corresponding 90% confidence intervals, with predefined equivalence limits of 80.00% to 125.00%.
Safety assessments will include adverse events, physical examinations, vital signs, 12-lead electrocardiograms, clinical laboratory tests, and blood glucose measurements. A post-study visit will be conducted between Day 43 and Day 47 after the final administration.
Korea United Pharm. Inc. is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy adult volunteers aged 19 years or older and younger than 65 years at screening.
Current or past history of hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, neoplastic, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, or other clinically significant diseases.
≥6.5%. 9. History of drug abuse or a positive urine drug screening test for drugs of abuse.
10. Abnormal vital signs measured in a sitting position after at least 3 minutes of rest at screening, including any of the following:
Pulse rate ≤40 bpm or ≥100 bpm. 11. Use of drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month before the first administration of the investigational product.
12. Use of any prescription medication or herbal medicine that may affect the characteristics of the investigational products within 2 weeks before the first administration, or use of any over-the-counter medication or health functional food within 10 days before the first administration. However, participation may be permitted at the investigator's discretion if the medication is not expected to affect the pharmacokinetic characteristics of the investigational products.
13. Participation in another clinical trial involving administration of an investigational product within 6 months before the first administration in this study. The day following the last administration in the previous clinical trial is considered Day 1.
14. Donation of whole blood within 2 months, donation of blood components within 1 month, or receipt of a blood transfusion within 1 month before the first administration, or inability to refrain from blood donation from the time of written until the post-study visit (PSV).
15. Regular alcohol consumption exceeding 21 units per week within 6 months before the first administration (1 unit = 10 g or 12.5 mL of pure alcohol), or inability to abstain from alcohol from the time of written informed consent until the PSV.
16. Smoking more than an average of 10 cigarettes per day within 3 months before the first administration, or inability to abstain from smoking from 24 hours before the first administration until the final blood sampling.
17. Consumption of grapefruit or grapefruit-containing foods within 72 hours before the first administration, or inability to abstain from such foods until the PSV.
18. Consumption of caffeine-containing foods or beverages (e.g., coffee, green tea, black tea, carbonated beverages, coffee-flavored milk, or energy drinks) within 24 hours before the first administration, or inability to abstain from such products until the final blood sampling.
19. Engagement in strenuous exercise exceeding the level of normal daily activities within 72 hours before the first administration, or inability to refrain from such exercise until the PSV.
20. Inability to maintain dietary habits and physical activity levels comparable to normal daily life from the time of written informed consent until the PSV.
21. Following an abnormal diet that may affect the absorption, distribution, metabolism, or excretion of the investigational products, or consuming foods that may affect drug metabolism.
22. Change in body weight of 5% or more within the previous 3 months. 23. Participants who, or whose spouse or partner, plan to become pregnant, or who do not use reliable even without pregnancy plans, from the time of written informed consent until 60 days after the final administration of the investigational product. Reliable contraceptive methods include implants or intrauterine devices, sterilization procedures (e.g., vasectomy or tubal ligation), and barrier methods (e.g., condoms, contraceptive diaphragms, vaginal sponges, or cervical caps used in combination).
24. Presence of tattoos, sunburn, thermal burns, or other skin abnormalities at the administration site, including cuts, bruising, erythema, induration, or tenderness, that may interfere with medical assessments before or after administration of the investigational products.
25. Participants considered unsuitable for participation in the clinical trial by the investigator for any reason other than the inclusion and exclusion criteria specified above.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single 0.5 mg subcutaneous dose of UIC202611 (reference product) in Period 1, followed by a single 0.5 mg subcutaneous dose of UI112 (test product) in Period 2, with a 6-week washout period between treatments.
Drug: Semaglutide (UI112) · Drug: Semaglutide (UIC202611)
Participants will receive a single 0.5 mg subcutaneous dose of UI112 (test product) in Period 1, followed by a single 0.5 mg subcutaneous dose of UIC202611 (reference product) in Period 2, with a 6-week washout period between treatments.
Drug: Semaglutide (UI112) · Drug: Semaglutide (UIC202611)
UI112 is the investigational semaglutide product developed by Korea United Pharm. Co., Ltd. A single 0.5 mg dose will be administered subcutaneously in each participant's assigned treatment period.
Also known as: UI112
UIC202611 is the reference product, Wegovy (semaglutide), manufactured by Novo Nordisk. A single 0.5 mg dose will be administered subcutaneously in each participant's assigned treatment period.
Also known as: Wegovy
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUCt) of Semaglutide
AUCt is the area under the plasma concentration-time curve from time zero to the last quantifiable concentration of semaglutide, calculated using the linear trapezoidal method.
Time frame: Pre-dose through 504 hours post-dose (Day 1 to Day 22) in each treatment period.
Maximum Observed Plasma Concentration (Cmax) of Semaglutide
Cmax is the maximum observed plasma concentration of semaglutide following a single subcutaneous administration of each study product.
Time frame: Pre-dose through 504 hours post-dose (Day 1 to Day 22) in each treatment period.
Area Under the Plasma Concentration-Time Curve From 0 to 168 Hours (AUC168h) of Semaglutide
AUC168h is the area under the plasma concentration-time curve of semaglutide from time zero to 168 hours after dosing.
Time frame: Pre-dose through 168 hours post-dose (Day 1 to Day 8) in each treatment period.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Semaglutide
AUCinf is the area under the plasma concentration-time curve of semaglutide from time zero extrapolated to infinity, calculated by noncompartmental analysis.
Time frame: Pre-dose through 504 hours post-dose (Day 1 to Day 22) in each treatment period.
Apparent Clearance (CL/F) of Semaglutide
CL/F is the apparent clearance of semaglutide following subcutaneous administration, estimated using noncompartmental pharmacokinetic analysis.
Time frame: Pre-dose through 504 hours post-dose (Day 1 to Day 22) in each treatment period.
Apparent Volume of Distribution (Vz/F) of Semaglutide
Vz/F is the apparent volume of distribution of semaglutide during the terminal phase following subcutaneous administration, estimated using noncompartmental analysis.
Time frame: Pre-dose through 504 hours post-dose (Day 1 to Day 22) in each treatment period.
Time to Maximum Observed Plasma Concentration (Tmax) of Semaglutide
Tmax is the observed time required to reach the maximum plasma concentration (Cmax) of semaglutide after dosing.
Time frame: Pre-dose through 504 hours post-dose (Day 1 to Day 22) in each treatment period.
Terminal Elimination Half-Life (t1/2) of Semaglutide
The terminal elimination half-life of semaglutide is calculated as ln(2)/lambda z, where lambda z is the terminal elimination rate constant estimated from the plasma concentration-time profile.
Time frame: Pre-dose through 504 hours post-dose (Day 1 to Day 22) in each treatment period.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
The number and percentage of participants experiencing adverse events and serious adverse events will be assessed. Adverse events will be summarized by severity, seriousness, and relationship to the study drug.
Time frame: From the first administration through the post-study visit (Day 43 to Day 47 after the final administration).
Plan to share: No — There is no current plan to share individual participant data (IPD) with external researchers. Study data will be managed by the sponsor in accordance with the study protocol, applicable regulations, and confidentiality requirements.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Nov 2027, 10 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide