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

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: tiotropium pMDI

• Registration Number: NCT03155204
• Lead Sponsor: Solventum US LLC

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 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.

Study Timeline

• Study Start: 2017-04-25
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-16
• Primary Completion: 2018-01-21
• Study Completion: 2018-03-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Product 4	tiotropium pMDI	tiotropium pMDI 2 inhalations
Commercial Product	tiotropium pMDI	tiotropium Respimat 2 inhalations
Test Product 1	tiotropium pMDI	tiotropium pMDI 2 inhalations
Test Product 2	tiotropium pMDI	tiotropium pMDI 2 inhalations
Test Product 3	tiotropium pMDI	tiotropium pMDI 2 inhalations

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	24 hr	noncompartmental analysis

Secondary Outcome Measures

Name	Time	Method
Adverse events	24 hr	reported adverse events
Area Under the Plasma Concentration vs Time Curve (AUC)	24 hr	trapezoidal rule

Trial Locations

Locations (1)

3M Health Care; 🇬🇧 Loughborough, United Kingdom