The purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
26
four inhalations
Quotient Clinical Ltd
Ruddington, Nottingham, United Kingdom
peak plasma concentration
measured by noncompartmental analysis
Time frame: 8 hours
adverse events
reported adverse events
Time frame: 8 hours
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