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The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Ultibro Breezhaler 2 capsules, Batch A | Experimental |
| |
| Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A | Experimental |
| |
| Part 1 Ultibro Breezhaler 1 capsule, Batch A | Experimental |
| |
| Part 2 Ultibro Breezhaler 2 capsules, Batch A | Experimental |
| |
| Part 2 Ultibro Breezhaler 2 capsules, Batch B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol maleate and glycopyrronium bromide | Drug | Batch A Ultibro Breezhaler 85/43 μg 2 capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak indacaterol concentration in plasma (Cmax) | between 0-72 hours after dosing | |
| Peak glycopyrronium concentration in plasma (Cmax) | between 0-72 hours after dosing | |
| Indacaterol area under the concentration-time curve from time zero to 30 minutes (AUC30min) | 0-30 minutes after dosing | |
| Glycopyrronium area under the concentration-time curve from time zero to 30 minutes (AUC30min) | 0-30 minutes after dosing | |
| Indacaterol area under the concentration-time curve from time zero to 72 hours (AUC72h) | 0-72 hours after dosing | |
| Glycopyrronium area under the concentration-time curve from time zero to 72 hours (AUC72h) | 0-72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt) | 0-18 days after dosing | |
| Glycopyrronium area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt) |
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Main inclusion criteria:
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orion Corporation Clinical Study Director | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRST Helsinki Oy | Helsinki | Finland |
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The study is a 2-part crossover study where the study subjects participate either in part 1 (18 subjects) or in part 2 (16 subjects). The parts can run in sequence or in parallel. The study subjects in part 1 receive single doses of Ultibro Breezhaler on 3 periods and the study subjects in part 2 receive single doses of Ultibro Breezhaler on 2 periods.
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| Indacaterol maleate and glycopyrronium bromide | Drug | Batch A Ultibro Breezhaler 85/43 μg 1 capsule |
|
| Indacaterol maleate and glycopyrronium bromide | Drug | Batch B Ultibro Breezhaler 85/43 μg 2 capsules |
|
| Ultibro Breezhaler with oral charcoal | Drug | Activated charcoal suspension, granules 50 g / bottle |
|
| 0-18 days after dosing |
| Indacaterol area under the concentration-time curve from time zero to infinity (AUCinf) | 0-18 days after dosing |
| Glycopyrronium area under the concentration-time curve from time zero to infinity (AUCinf) | 0-18 days after dosing |
| Time to reach peak indacaterol concentration in plasma | between 0-72 hours after dosing |
| Time to reach peak glycopyrronium concentration in plasma | between 0-72 hours after dosing |
| Indacaterol terminal elimination half-life (t1/2) | 0-18 days after dosing |
| Glycopyrronium terminal elimination half-life (t1/2) | 0-18 days after dosing |
| Number of adverse events as event counts and subjects counts | throughout the study, average 9-12 weeks |
| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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