Completed

Tiotropium Steady-state Pharmacokinetics in Healthy Volunteers

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Study Aim

This study aims to evaluate the peak plasma concentration of Tiotropium in healthy volunteers to understand its steady-state pharmacokinetics.

What is being tested

Tiotropium

Drug
Who is being recruted

Pathologic Processes+2

+ Respiration Disorders

+ Respiratory Tract Diseases

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: July 2017
See protocol details

Summary

Principal SponsorKindeva Drug Delivery
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 13, 2017

Actual date on which the first participant was enrolled.

This study is focused on understanding how a new test inhaler product delivers the medication tiotropium in the body compared to an existing inhaler product, Spiriva Respimat. The study involves healthy male and female volunteers and is designed to observe how the body processes the medication over time. By comparing the two inhalers, researchers aim to gather information that could lead to improved delivery methods for respiratory medications, potentially benefiting patients who need better treatment options for managing their breathing conditions. Participants in the study will use both the test inhaler and the reference inhaler in a sequence over 28 days. They will switch between the two inhalers during the study period, which is called a crossover design. Blood samples will be taken from participants before and after they use the inhalers to measure the levels of tiotropium in the bloodstream, focusing on the peak concentration after dosing. This approach helps scientists determine how effectively each inhaler delivers the medication and how long it stays active in the body. The study carefully monitors this to ensure accurate and safe comparisons.

Official TitleProtocol With Amendments 1 and 2: Phase I Randomised, Two-period 21 Day Crossover Study in Healthy Male and Female Volunteers to Compare the Steadystate Pharmacokinetics of Tiotropium Delivered From a Test pMDI Product With Spiriva Respimat
NCT03246581
Principal SponsorKindeva Drug Delivery
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesRespiration DisordersRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsRespiratory Aspiration

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
tiotropium pMDI 2 inhalations

Group II

Experimental
tiotropium pMDI 2 inhalations

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

3M Health Care

Loughborough, United KingdomOpen 3M Health Care in Google Maps
CompletedOne Study Center