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A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Evaluate Bioequivalence After Dry-powder Inhalation of UIC202005 or UI009 in Healty Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UI009 | Experimental |
| |
| UIC202005 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UI009 | Drug | inhale UI009 twice a day on Day 1 and Day 8. |
| |
| UIC202005 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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).
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | Daejeon | 35015 | South Korea |
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| Drug |
inhale UIC202005 twice a day on Day 1 and Day 8. |
|