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This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium Easyhaler 10 microg/dose, Product variant J | Experimental | Each subject will receive a single dose of 2 inhaled doses from Tiotropium Easyhaler Product variant J in one of the three periods (cross-over). The total dose is 20 micrograms of tiotropium (delivered dose) as Tiotropium Bromide Monohydrate. |
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| Tiotropium Easyhaler 10 microg/dose, Product variant K | Experimental | Each subject will receive a single dose of 2 inhaled doses from Tiotropium Easyhaler Product variant K in one of the three periods (cross-over). The total dose is 20 micrograms of tiotropium (delivered dose) as Tiotropium Bromide Monohydrate. |
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| Spiriva HandiHaler 18 microg/capsule | Active Comparator | Each subject will receive a single dose of 2 inhaled Spiriva capsules via HandiHaler device in one of the three periods (cross-over). The total dose is 20 micrograms of tiotropium (delivered dose) as Tiotropium Bromide Monohydrate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Bromide Monohydrate | Drug | In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler |
| 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) | between 0-30 minutes after dosing | |
| Area under the concentration-time curve from time zero to 72 hours (AUC72 hours) | between 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 | throughout the study, an average 7 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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| ID | Term |
|---|---|
| D006244 | Hardness |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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Bioanalytical laboratory will be blinded with regard to the sequence of the product administration
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