Healthy Clinical Trial
Official title:
Phase I Randomised, Four-period Balanced Incomplete Block Design Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With One Reference Product
Verified date | October 2017 |
Source | 3M |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.
Status | Completed |
Enrollment | 38 |
Est. completion date | January 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
3M |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax | maximum plasma concentration | 48 hours |
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