HealthPhase 1NCT07110740
Bioequivalence Study Between UI009 and UIC202005 in Healthy Subjects
A Phase 1 study testing UI009 and UIC202005 in people with Health, run by Korea United Pharm. Inc. at 1 site in South Korea.
Trial summary
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Evaluate Bioequivalence After Dry-powder Inhalation of UIC202005 or UI009 in Healty Volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health
- What is being tested?
- UI009 and UIC202005
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Oct 2024to 13 Dec 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 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 time of screening.
- Subjects whose body weight is at least 55 kg and with a body mass index (BMI) between 18.0 and 30.0 kg/m².
- Subjects confirmed as healthy based on screening tests including vital signs, laboratory tests (hematology, biochemistry, urinalysis), and electrocardiogram (ECG), performed within 28 days prior to the first administration of the investigational product.
- Female subjects who are not pregnant or breastfeeding, and who do not plan to become pregnant or breastfeed within 7 days after the last administration of the investigational product.
- Subjects without congenital or chronic disease, and with no clinical significance based on physical examination.
- Subjects who agree not to donate sperm (for males) or ova (for females), and whose partners agree to use medically acceptable contraception from the first administration to 7 days after the last dose.
- Subjects able to read and understand a written informed consent, and willing to participate in the study.
Who cannot join
- Subjects with any of the following medical histories or conditions deemed by the investigator to potentially interfere with the study:
- Hypersensitivity to components of the investigational product or to other drugs such as aspirin or antibiotics
- Hypersensitivity to sympathomimetic agents
- hypersensitivity to inhaled lactose (allergic), galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Cardiovascular disorders
- Infectious respiratory diseases, especially tuberculosis or suspected infectious chronic obstructive pulmonary disease
Show all 33Show fewer
- Moderate to severe bronchiectasis
- Asthma or COPD requiring emergency treatment
- Hypokalemia
- Hepatic dysfunction
- Hyperthyroidism
- Seizure disorders
- Subjects with a history of taking or currently taking medications deemed by the investigator to potentially interfere with the study
- Drugs known to interact with the investigational product or related drug classes (e.g., CYP3A4 inhibitors, beta-adrenergic agents, catecholamines, steroids, diuretics)
- Enzyme-inducing or enzyme-inhibiting drugs (e.g., barbiturates) taken within 1 month prior to the first administration of the investigational product
- Any prescription drugs taken within 10 days prior to the first administration of the investigational product
- Any over-the-counter medications, including health supplements, herbal medicines, or dietary supplements, taken within 10 days prior to the first administration
- Subjects who meet any of the following criteria during screening (including re-tests), and are deemed by the investigator to have clinically significant findings
- Systolic blood pressure < 90 mmHg or > 140 mmHg
- Diastolic blood pressure < 55 mmHg or > 90 mmHg
- AST (GOT) or ALT (GPT) > 2.0 × upper limit of reference range
- Serum potassium below the lower limit of the reference range
- TSH below the lower limit of the reference range
- FEV₁ or FEV₁/FVC outside the reference range
- Positive results for serum tests: RPR Ab, HIV Ag/Ab, HBs Ag, HCV Ab
- Positive result for any drug of abuse in the urine drug screening
- Subjects who donated whole blood within 8 weeks, donated blood components within 4 weeks, or received a blood transfusion within 4 weeks prior to the first administration of the investigational product, or who plan to do so during the study period.
- Subjects who consumed more than 5 cups/day (1 cup = 250 mL) of grapefruit-containing or caffeine-containing products within 3 months prior to the first administration, or who are unable to abstain from such consumption from 72 hours prior to dosing until the last pharmacokinetic blood sampling of each period.
- Subjects who consumed more than 210 g/week of alcohol within 3 months prior to the first administration of the investigational product, or who are unable to abstain from alcohol from 72 hours prior to dosing until the last pharmacokinetic blood sampling of each period.
- Subjects who smoked more than 10 cigarettes/day within 3 months prior to the first administration of the investigational product, or who are unable to abstain from smoking from 72 hours prior to dosing until the last pharmacokinetic blood sampling of each period.
- Subjects who participated in another clinical trial and received an investigational drug within 6 months prior to the first administration (based on the last dosing date in the previous trial).
- Subjects who are unable to consume the standard meals provided by the study center.
- Subjects who are deemed by the investigator to be otherwise unsuitable for participation in the study for reasons not covered by the above exclusion criteria.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Daejeon, Daejeon, 35015
About this study
Official title: A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Evaluate Bioequivalence After Dry-powder Inhalation of UIC202005 or UI009 in Healty Volunteers
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Evaluate Bioequivalence After Dry-powder Inhalation of UIC202005 or UI009 in Healty Volunteers
- Conditions
- Health
- Being tested
- UI009, UIC202005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UI009Drug
inhale UI009 twice a day on Day 1 and Day 8.
UIC202005Drug
inhale UIC202005 twice a day on Day 1 and Day 8.
| Study group | Role | What they receive |
|---|---|---|
| UI009 | Experimental | Not described Receives: Drug: UI009 |
| UIC202005 | Active comparator | Not described Receives: Drug: UIC202005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Fluticasone propionate
Cmax(maxium concentration)
Measured: Day 1 and Day 8: 0, 0.017, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 hr
AUClast of Fluticasone propionate
Area under the curve to the last measurable concentration
Measured: Day1 and Day8: 0, 0.017, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36hr
AUC0.5hr of Salmeterol
Area under the curve from time 0 to 0.5 hours
Measured: Day1 and Day8: 0, 0.17, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5hr
AUClast of salmeterol
Area under the curve to the last measurable concentration
Measured: Day1 and Day8: 0, 0.017, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36hr
Cmax of Salmeterol
Cmax(maxium concentration)
Measured: Day1 and Day8: 0, 0.017, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start24 Oct 2024
- Primary completion29 Nov 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies 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
- 30 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
- NCT07110740
- Sponsor's protocol ID
- KUP-UI009-103
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 8 Aug 2025
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Evaluate Bioequivalence After Dry-powder Inhalation of UIC202005 or UI009 in Healty Volunteers
- ClinicalTrials.gov ID
- NCT07110740
- Acronym / sponsor ID
- KUP-UI009-103
- Conditions
- Health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 8 Aug 2025 (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, Single-dosing, 2x2 Crossover Study to Evaluate Bioequivalence After Dry-powder Inhalation of UIC202005 or UI009 in Healty Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI009 | Experimental | Drug: UI009 |
| UIC202005 | Active comparator | Drug: UIC202005 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects aged 19 years or older at the time of screening.
- Subjects whose body weight is at least 55 kg and with a body mass index (BMI) between 18.0 and 30.0 kg/m².
- Subjects confirmed as healthy based on screening tests including vital signs, laboratory tests (hematology, biochemistry, urinalysis), and electrocardiogram (ECG), performed within 28 days prior to the first administration of the investigational product.
- Female subjects who are not pregnant or breastfeeding, and who do not plan to become pregnant or breastfeed within 7 days after the last administration of the investigational product.
- Subjects without congenital or chronic disease, and with no clinical significance based on physical examination.
Key exclusion criteria (33 listed)
- Subjects with any of the following medical histories or conditions deemed by the investigator to potentially interfere with the study:
- Subjects with a history of taking or currently taking medications deemed by the investigator to potentially interfere with the study
- Subjects who meet any of the following criteria during screening (including re-tests), and are deemed by the investigator to have clinically significant findings
- Subjects who donated whole blood within 8 weeks, donated blood components within 4 weeks, or received a blood transfusion within 4 weeks prior to the first administration of the investigational product, or who plan to do so during the study period.
- Subjects who consumed more than 5 cups/day (1 cup = 250 mL) of grapefruit-containing or caffeine-containing products within 3 months prior to the first administration, or who are unable to abstain from such consumption from 72 hours prior to dosing until the last pharmacokinetic blood sampling of each period.
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 |
|---|---|---|
| UI009inhale UI009 twice a day on Day 1 and Day 8. | Drug | UI009 |
| UIC202005inhale UIC202005 twice a day on Day 1 and Day 8. | Drug | UIC202005 |
Primary outcome
Cmax of Fluticasone propionate
Time frame: Day 1 and Day 8: 0, 0.017, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 hr
Cmax(maxium concentration)
AUClast of Fluticasone propionate
Time frame: Day1 and Day8: 0, 0.017, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36hr
Area under the curve to the last measurable concentration
AUC0.5hr of Salmeterol
Time frame: Day1 and Day8: 0, 0.17, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5hr
Area under the curve from time 0 to 0.5 hours
AUClast of salmeterol
Time frame: Day1 and Day8: 0, 0.017, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36hr
Area under the curve to the last measurable concentration
Cmax of Salmeterol
Time frame: Day1 and Day8: 0, 0.017, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36hr
Cmax(maxium concentration)
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 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Health
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
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 UI009 and UIC202005 in people with Health, 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 33 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 Aug 2025. 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?
Cmax of Fluticasone propionate (time frame: Day 1 and Day 8: 0, 0.017, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 hr). The study lists 5 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 Aug 2025.