Clinical trial NCT02676297: Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: inhalation
anticholinergic
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: Quotient Clinical
name: 3M
First posted: 2016-02-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: peak plasma concentration
timeFrame: 8 hours
Secondary outcomes:
measure: adverse events
timeFrame: 8 hours
Other outcomes:
measure: area under the plasma concentration vs. time curve
timeFrame: 8 hours
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical Ltd
state: Nottingham
Study officials:
affiliation: Quotient Clinical
name: Pui Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: