The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.
Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and one reference inhalation product according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
46
inhalation
3M Health Care
Loughborough, United Kingdom
Peak Plasma Concentration (Cmax)
noncompartmental analysis
Time frame: 24 hr
Adverse events
reported adverse events
Time frame: 24 hr
Area Under the Plasma Concentration vs Time Curve (AUC)
trapezoidal rule
Time frame: 24 hr
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