Overview

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

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
3M
Collaborators:
Quotient
Quotient Clinical
Treatments:
Tiotropium Bromide
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)