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 range19 Years

SexALL

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:
✕. 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.
✕. 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).

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 range19 Years

SexALL

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:
✕. 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.
✕. 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).

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