Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products

Study Overview
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Brief Summary
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The purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers.

Detailed Description
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Healthy subjects will be enrolled and will receive single doses of 2 test inhalation products and one reference inhalation product according to a three-period cross-over design. Subjects will use the patient instruction leaflet to understand how each inhaler is administered. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

Official Title
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Phase I Randomised, Three-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Two Test Products With Spiriva Respimat Comparator Product

Conditions
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Healthy

Intervention / Treatment
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* Drug: tiotropium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteer Willing and able to give informed consent Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration Exclusion Criteria: Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders Any presence or history of a clinically significant allergy including any adverse reaction to study drug History of drug or alcohol abuse within the past 2 years Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked) Donation or loss of greater than 400 mL of blood within the previous 3 months Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted) Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days) Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months If female, nursing, lactating or pregnant Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Test product A<br>tiotropium | Drug: tiotropium<br>* four inhalations<br>* Other names: Spiriva Respimat;|
| Experimental: Test product B<br>tiotropium | Drug: tiotropium<br>* four inhalations<br>* Other names: Spiriva Respimat;|
| Active Comparator: reference product<br>tiotropium | Drug: tiotropium<br>* four inhalations<br>* Other names: Spiriva Respimat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak plasma concentration | measured by noncompartmental analysis | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | reported adverse events | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inhalation, anticholinergic