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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246581
• Other study ID #: CSP-07-000040
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2017
• Est. completion date: May 3, 2018

Study information

• Verified date: July 2018
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 3, 2018
• Est. primary completion date: January 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tiotropium
inhalation

Locations

Country	Name	City	State
United Kingdom	3M Health Care	Loughborough

Sponsors (2)

Lead Sponsor	Collaborator
3M	Simbec Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	noncompartmental analysis	24 hours