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

Phase I Randomised, Four-period Balanced Incomplete Block Design Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With One Reference Product

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03302065

Enrollment

Registered

2017-10-04

Start date

2016-05-31

Completion date

2017-01-31

Last updated

2024-12-02

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 four different inhalation products with the reference product in healthy volunteers.

Detailed description

Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and two reference inhalation products according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 48 hours post-dose.

Interventions

DRUGTiotropium

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 * 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)

Design outcomes

Primary

Measure	Time frame	Description
Cmax	48 hours	maximum plasma concentration

Outcome results

None listed

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