CompletedPhase 1

Bioequivalence Study Between UI009 and UIC202005 in Healthy Subjects

South Korea30 participantsStarted 2024-10-24

Plain-language summary

A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Evaluate Bioequivalence After Dry-powder Inhalation of UIC202005 or UI009 in Healty Volunteers

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Subjects with any of the following medical histories or conditions deemed by the investigator to potentially interfere with the study:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax of Fluticasone propionate

Timeframe: 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

Timeframe: 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

Timeframe: Day1 and Day8: 0, 0.17, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5hr

AUClast of salmeterol

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT07110740

SponsorKorea United Pharm. Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-29

View on ClinicalTrials.gov More Health trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Subjects with any of the following medical histories or conditions deemed by the investigator to potentially interfere with the study:

What they're measuring

Cmax of Fluticasone propionate

Timeframe: 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

Timeframe: 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

Timeframe: Day1 and Day8: 0, 0.17, 0.033, 0.067, 0.1, 0.167, 0.333, 0.5hr

AUClast of salmeterol

Timeframe: 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

Timeframe: 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