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

July 2, 2018 updated by: 3M

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Product
tiotropium pMDI 2 inhalations
Drug: Tiotropium
inhalation
Other Names:
  • Spiriva Respimat
Active Comparator: Commercial Product
tiotropium pMDI 2 inhalations
Drug: Tiotropium
inhalation
Other Names:
  • Spiriva Respimat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: 24 hours
noncompartmental analysis
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Collaborators

Simbec Research

Investigators

  • Study Chair: Victoria Sessions, PhD, 3M

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2017

Primary Completion (Actual)

January 21, 2018

Study Completion (Actual)

May 3, 2018

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-07-000040

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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