Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetic Pilot Study Comparing Absorption of Inhaled Tiotropium Between Tiotropium Easyhaler® Products and Spiriva® Capsules Delivered Via HandiHaler®

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Tiotropium Bromide Monohydrate
* Drug: Tiotropium Bromide Monohydrate
* Drug: Tiotropium Bromide Monohydrate
* Drug: Tiotropium Bromide Monohydrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects 18-60 years old Body mass index >19 and <30 kg/m2 Weight at least 50 kg Written informed consent obtained Exclusion Criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, 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 may interfere with the interpretation of study results or constitute 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 proper contraception. Blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tiotropium Easyhaler Product A<br>tiotropium bromide monohydrate 2 inhalations as a single dose | Drug: Tiotropium Bromide Monohydrate<br>* Tiotropium Easyhaler 10 mcg/dose Product A<br>|
| Experimental: Tiotropium Easyhaler Product B<br>tiotropium bromide monohydrate 2 inhalations as a single dose | Drug: Tiotropium Bromide Monohydrate<br>* Tiotropium Easyhaler 10 mcg/dose Product B<br>|
| Experimental: Tiotropium Easyhaler Product C<br>tiotropium bromide monohydrate 2 inhalations as a single dose | Drug: Tiotropium Bromide Monohydrate<br>* Tiotropium Easyhaler 10 mcg/dose Product C<br>|
| Active Comparator: Spiriva HandiHaler<br>tiotropium bromide monohydrate 2 Spiriva capsules inhaled via HandiHaler | Drug: Tiotropium Bromide Monohydrate<br>* Spiriva 18 Mcg/capsule inhaled via HandiHaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

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