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Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium Easyhaler Product variant D | Experimental |
| |
| Tiotropium Easyhaler Product variant E | Experimental |
| |
| Tiotropium Easyhaler Product variant F | Experimental |
| |
| Tiotropium Easyhaler Product variant G | Experimental |
| |
| Tiotropium Easyhaler Product variant H | Experimental |
| |
| Spiriva HandiHaler | Active Comparator |
| |
| Tiotropium Easyhaler Product variant F administered with oral activated charcoal | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Bromide Monohydrate | Drug | Tiotropium Easyhaler 10 µg/dose Product variant D |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak tiotropium concentration in plasma (Cmax) | between 0-72 hours after dosing | |
| Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes) | 0-30 minutes after dosing | |
| Area under the concentration-time curve from time zero to 72 hours (AUC72 hours) | 0-72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach peak concentration in plasma (tmax) | between 0-72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | througout the study, an average 9 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit, Orion Corporation | Espoo | Finland |
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The study is a 2-part 4-period crossover study where the study subjects participate either in part 1 (20 subjects) or in part 2 (20 subjects). Parts can run in sequence or parallel. All study subjects receive single dose of Tiotropium Easyhaler on 3 periods and Spiriva HandiHaler on 1 period.
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Bioanalytical laboratory will be blinded with regard to the sequence of the product administration.
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| Tiotropium Bromide Monohydrate | Drug | Tiotropium Easyhaler 10 µg/dose Product variant E |
|
| Tiotropium Bromide Monohydrate | Drug | Tiotropium Easyhaler 10 µg/dose Product variant F |
|
| Tiotropium Bromide Monohydrate | Drug | Tiotropium Easyhaler 10 µg/dose Product variant G |
|
| Tiotropium Bromide Monohydrate | Drug | Tiotropium Easyhaler 10 µg/dose Product variant H |
|
| Tiotropium Bromide Monohydrate | Drug | Spiriva 18 µg/capsule inhaled via Handihaler |
|
| Tiotropium Easyhaler with oral activated charcoal | Drug | The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F |
|
| ID | Term |
|---|---|
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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