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This is a formulation feasibility study to to compare relative bioavailability of indacaterol and glycopyrronium after administration of single doses of 3 Easyhaler test products and Ultibro Breezhaler. The study treatments will be administered with concomitant oral charcoal to block absorption via gastrointestinal tract and to assess pulmonary absorption only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A | Experimental | Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant A in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). |
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| Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B | Experimental | Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant B in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). |
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| Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C | Experimental | Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant C in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). |
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| Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule | Active Comparator | Each subject will receive 2 capsules of Ultibro® Breezhaler® (=Indacaterol/glycopyrronium) as a single dose in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol/glycopyrronium | Drug | In each period, subjects receive single dose of indacaterol/glycopyrronium consisting of 2 inhaled doses via Easyhaler or 2 capsules inhaled via Ultibro Breezhaler. In addition to study treatments, activated charcoal will be administered on each study period before and after study drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak indacaterol and glycopyrronium concentration in plasma (Cmax) | Pharmacokinetic parameters of indacaterol and glycopyrronium | between 0-72 hours after dosing |
| Area under the concentration-time curve from time zero to 72 hours (AUC72) | Pharmacokinetic parameters of indacaterol and glycopyrronium | between 0-72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax) | Pharmacokinetic parameters of indacaterol and glycopyrronium | between 0-72 hours after dosing |
| Area under the concentration-time curve from time zero to 30 minutes (AUC30) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events | Up to 11 weeks |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orion Corporation Clinical Study Director | Orion Corporation, Orion Pharma | Study Director |
| 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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| ID | Term |
|---|---|
| C510790 | indacaterol |
| D006024 | Glycopyrrolate |
| D002606 | Charcoal |
| D006244 | Hardness |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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Bioanalytical laboratory will be blinded with regard to the sequence of the product administration.
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Pharmacokinetic parameters of indacaterol and glycopyrronium |
| between 0-30 minutes after dosing |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |