The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)
Time frame: Up to 96 hours after drug administration
Time to achieve Cmax (tmax)
Time frame: Up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)
Time frame: Up to 96 hours after drug administration
Terminal rate constant in plasma (λ)
Time frame: Up to 96 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 96 hours after drug administration
Mean residence time of the analyte (MRT)
Time frame: Up to 96 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: Up to 96 hours after drug administration
Apparent volume of distribution following extravascular administration (Vd/F)
Time frame: Up to 96 hours after drug administration
Number of patients with clinically relevant changes from baseline in laboratory values
Time frame: Baseline, up to day 5 after last drug administration
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Number of Participants with Adverse Events
Time frame: Up to day 5 after last drug administration
Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure)
Time frame: Baseline, up to day 5 after last drug administration
Global assessment of tolerability by investigator on a 4-point scale
Time frame: Day 5 after last drug administration