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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tiotropium

• Registration Number: NCT03246581
• Lead Sponsor: Solventum US LLC

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.

Study Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-11
• Primary Completion: 2018-01-21
• Study Completion: 2018-05-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Product	Tiotropium	tiotropium pMDI 2 inhalations
Commercial Product	Tiotropium	tiotropium pMDI 2 inhalations

Primary Outcome Measures

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

Trial Locations

Locations (1)

3M Health Care; 🇬🇧 Loughborough, United Kingdom