Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-13

Study Completion Date

2018-05-03

Brief Summary

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The purpose of this study is to compare the absorption of a test inhalation product with the reference product in healthy volunteers.

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Detailed Description

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Healthy subjects will be enrolled and will receive doses of a test inhalation product and a reference inhalation product for 28 days according to a crossover design. Plasma tiotropium levels will be measured predose and over 24 hours postdose on days 1 and 28.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Test Product

tiotropium pMDI 2 inhalations

Group Type EXPERIMENTAL

Tiotropium

Intervention Type DRUG

inhalation

Commercial Product

tiotropium pMDI 2 inhalations

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

inhalation

Interventions

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Tiotropium

inhalation

Intervention Type DRUG

Other Intervention Names

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Spiriva Respimat

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes