Bioequivalence Study Between UI009 and UIC202005 in Healthy Subjects

NCT07110740 | Completed Phase 1

• 1 other identifier: KUP-UI009-103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (5)

• Cmax of Fluticasone propionate

  Cmax(maxium concentration)

  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

  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

  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

  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)

  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

Study Arms (2)

UI009

EXPERIMENTAL

Drug: UI009

UIC202005

ACTIVE COMPARATOR

Drug: UIC202005

Interventions

UI009 DRUG

inhale UI009 twice a day on Day 1 and Day 8.

UI009

UIC202005 DRUG

inhale UIC202005 twice a day on Day 1 and Day 8.

UIC202005

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, Daejeon, 35015, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 8, 2025
• Study Start: October 24, 2024
• Primary Completion: November 29, 2024
• Study Completion: December 13, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-07

Locations

KR (1)