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

NCT02676297 | Completed Phase 1 DMC

• 2 other identifiers: CSP-07-0000272015-004145-10
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

inhalation; anticholinergic

Outcome Measures

Primary Outcomes (1)

• peak plasma concentration

  measured by noncompartmental analysis

  8 hours

Secondary Outcomes (1)

• adverse events

  8 hours

Other Outcomes (1)

• area under the plasma concentration vs. time curve

  8 hours

Study Arms (3)

Test product A

EXPERIMENTAL

tiotropium

Drug: tiotropium

Test product B

EXPERIMENTAL

tiotropium

Drug: tiotropium

reference product

ACTIVE COMPARATOR

tiotropium

Drug: tiotropium

Interventions

tiotropium DRUG

four inhalations

Also known as: Spiriva Respimat

Test product A; Test product B; reference product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Solventum US LLC: lead
• Quotient Clinical: collaborator
• 3M: collaborator

Study Sites (1)

Quotient Clinical Ltd

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Pui Leung, MD

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 8, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)