Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products

November 27, 2024 updated by: Solventum US LLC

Phase I Randomised, Three-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Two Test Products With Spiriva Respimat Comparator Product

The purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy subjects will be enrolled and will receive single doses of 2 test inhalation products and one reference inhalation product according to a three-period cross-over design. Subjects will use the patient instruction leaflet to understand how each inhaler is administered. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

Study Type

Interventional

Enrollment (Actual)

26

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

  • United Kingdom
    • Nottingham
      • Ruddington, Nottingham, United Kingdom, NG11 6JS
        • Quotient Clinical Ltd

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

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
  • 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 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 A
tiotropium
Drug: tiotropium
four inhalations
Other Names:
  • Spiriva Respimat
Experimental: Test product B
tiotropium
Drug: tiotropium
four inhalations
Other Names:
  • Spiriva Respimat
Active Comparator: reference product
tiotropium
Drug: tiotropium
four inhalations
Other Names:
  • Spiriva Respimat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peak plasma concentration
Time Frame: 8 hours
measured by noncompartmental analysis
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 8 hours
reported adverse events
8 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
area under the plasma concentration vs. time curve
Time Frame: 8 hours
measured by the trapezoidal rule
8 hours

Collaborators and Investigators

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

Sponsor

Solventum US LLC

Collaborators

Quotient Clinical
3M

Investigators

  • Principal Investigator: Pui Leung, MD, Quotient Clinical

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

January 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimated)

February 8, 2016

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-07-000027
  • 2015-004145-10 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

will share summary data

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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