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)