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Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium Easyhaler Product A | Experimental | tiotropium bromide monohydrate 2 inhalations as a single dose |
|
| Tiotropium Easyhaler Product B | Experimental | tiotropium bromide monohydrate 2 inhalations as a single dose |
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| Tiotropium Easyhaler Product C | Experimental | tiotropium bromide monohydrate 2 inhalations as a single dose |
|
| Spiriva HandiHaler | Active Comparator | tiotropium bromide monohydrate 2 Spiriva capsules inhaled via HandiHaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Bromide Monohydrate | Drug | Tiotropium Easyhaler 10 mcg/dose Product A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of tiotropium | between 0-72 hours after dosing | |
| Area under the concentration-time curve (AUC) of tiotropium from time zero to 72 h after the study treatment administration | 0-72 hours after dosing | |
| Truncated area under the concentration-time curve (AUC) of tiotropium from time zero to 30 min after study treatment administration | 0-30 minutes after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach peak concentration in plasma (tmax) of tiotropium | between 0-72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | throughout the study, an average of 10 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulla Sairanen, MSc | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Espoo | Finland |
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| Tiotropium Bromide Monohydrate | Drug | Tiotropium Easyhaler 10 mcg/dose Product B |
|
| Tiotropium Bromide Monohydrate | Drug | Tiotropium Easyhaler 10 mcg/dose Product C |
|
| Tiotropium Bromide Monohydrate | Drug | Spiriva 18 Mcg/capsule inhaled via HandiHaler |
|