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Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product

NCT ID: NCT03155204

Last Updated: 2024-12-02

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

EARLY_PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-25

Study Completion Date

2018-03-19

Brief Summary

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The purpose of this study is to compare the absorption of four 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 4 test inhalation products and one reference inhalation product according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

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 1

tiotropium pMDI 2 inhalations

Group Type EXPERIMENTAL

tiotropium pMDI

Intervention Type DRUG

inhalation

Test Product 2

tiotropium pMDI 2 inhalations

Group Type EXPERIMENTAL

tiotropium pMDI

Intervention Type DRUG

inhalation

Test Product 3

tiotropium pMDI 2 inhalations

Group Type EXPERIMENTAL

tiotropium pMDI

Intervention Type DRUG

inhalation

Test Product 4

tiotropium pMDI 2 inhalations

Group Type EXPERIMENTAL

tiotropium pMDI

Intervention Type DRUG

inhalation

Commercial Product

tiotropium Respimat 2 inhalations

Group Type ACTIVE_COMPARATOR

tiotropium pMDI

Intervention Type DRUG

inhalation

Interventions

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tiotropium pMDI

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
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria Sessions, PhD

Role: STUDY_CHAIR

3M

Locations

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3M Health Care

Loughborough, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CSP-07-000039

Identifier Type: -

Identifier Source: org_study_id