Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetic Study to Compare Tiotropium Easyhaler® Product Variants and Spiriva® 18 µg Capsules Administered Via HandiHaler® in Healthy Volunteers.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Tiotropium Bromide Monohydrate


Participation Criteria
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Eligibility Criteria
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Main inclusion criteria: Healthy male and female 18-60 years of age Body mass index 19-30 kg/m2 Weight at least 50 kg FEV1 at least 80% of the predicted value measured at screening Written informed consent obtained Main exclusion criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease. Any condition requiring regular concomitant treatment. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or lactose. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tiotropium Easyhaler 10 microg/dose, Product variant J<br>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. | Drug: Tiotropium Bromide Monohydrate<br>* In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler<br>* Other names: SPIRIVA® 18 microgram, inhalation powder, hard capsule inhaled via HandiHaler;|
| Experimental: Tiotropium Easyhaler 10 microg/dose, Product variant K<br>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. | Drug: Tiotropium Bromide Monohydrate<br>* In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler<br>* Other names: SPIRIVA® 18 microgram, inhalation powder, hard capsule inhaled via HandiHaler;|
| Active Comparator: Spiriva HandiHaler 18 microg/capsule<br>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. | Drug: Tiotropium Bromide Monohydrate<br>* In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler<br>* Other names: SPIRIVA® 18 microgram, inhalation powder, hard capsule inhaled via HandiHaler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach peak concentration in plasma (tmax) |  | between 0-72 hours after dosing |