Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Analysis of plasma concentration-time course after topical dose
Time frame: up to 264 hours after first topical administration
Determination of the ratio AUCss topical/AUC0-∞ oral
Time frame: up to 96 hours after oral administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 96 hours after oral administration
Time from dosing to the maximum concentration of the analyte in plasma (Tmax)
Time frame: up to 96 hours after oral administration
Total area under the plasma drug concentration time curve (AUC) from time of administration to the time of the last quantifiable drug concentration (AUC0-t)
Time frame: up to 96 hours after oral administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 96 hours after oral administration
Terminal half-life of the analyte in plasma (t½)
Time frame: up to 96 hours after oral administration
Apparent terminal elimination rate constant
Time frame: up to 96 hours after oral administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: up to 96 hours after oral administration
Apparent volume of distribution of the analyte during the terminal phase (Vz/F)
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Time frame: up to 96 hours after oral administration
Mean residence time (MRTtot)
Time frame: up to 96 hours after oral administration
Excretion of metabolites in urine
Time frame: 0-24 hours after oral administration
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time frame: up to 264 hours after first topical administration
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: up to 264 hours after first topical administration
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: up to 264 hours after first topical administration
Total area under the plasma drug concentration time curve (AUC) during a steady state interval (AUCss)
Time frame: up to 264 hours after first topical administration
Terminal half-life of the analyte in plasma (t½)
Time frame: up to 264 hours after first topical administration
Apparent terminal elimination rate constant
Time frame: up to 264 hours after first topical administration
Occurence of adverse events
Time frame: up to 24 days
Assessment of local and systemic tolerability
Time frame: up to 24 days