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

Protocol 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03246581

Enrollment

Registered

2017-08-11

Start date

2017-07-13

Completion date

2018-05-03

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

inhalation, anticholinergic

Brief summary

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

Detailed description

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.

Interventions

DRUGTiotropium

inhalation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax)	24 hours	noncompartmental analysis

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026