Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg meloxicam injection in comparison to the 15 mg oral tablet
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
AUC0-inf (total area under the plasma drug concentration-time curve)
Time frame: up to 96 hours after drug administration
Cmax (Maximum drug plasma concentration)
Time frame: up to 96 hours after drug administration
tmax (Time to achieve Cmax)
Time frame: up to 96 hours after drug administration
AUC0-t (Total area under the plasma drug concentration-time curve from time of administration to the time of the last quantifiable drug concentration)
Time frame: up to 96 hours after drug administration
λz (apparent terminal elimination rate constant)
Time frame: up to 96 hours after drug administration
t1/2 (apparent terminal elimination half-life)
Time frame: up to 96 hours after drug administration
MRTtot (Mean residence time)
Time frame: up to 96 hours after drug administration
CL/f (Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration)
Time frame: up to 96 hours after drug administration
Vz/f (Apparent volume of distribution during the terminal phase λz following extravascular administration)
Time frame: up to 96 hours after drug administration
Change from baseline in vital signs (pulse rate, systolic and diastolic blood pressure)
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Time frame: Baseline, days 1-5 of each treatment period
Change from baseline in laboratory parameters
Time frame: Baseline, days 1-2 and 5 of each treatment period
Number of patients with adverse events
Time frame: up to 72 hours after day 5 of each treatment period
Tolerability of the intramuscular injection
Time frame: before and 4 and 24 hours after application of study drug