The purpose of this study is to compare the absorption of three different inhalation products with the reference products in healthy volunteers.
Healthy subjects will be enrolled and will receive single doses of 3 test inhalation products and two reference inhalation products 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
31
4 inhalations
Quotient Clinical Ltd
Ruddington, Nottingham, United Kingdom
Peak Plasma Concentration (Cmax)
noncompartmental analysis
Time frame: 8 hours
Adverse events
reported adverse events
Time frame: 8 hours
Area Under the Plasma Concentration vs Time Curve (AUC)
trapezoidal rule
Time frame: 8 hours
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