To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the conventional formulation of WAL 801 CL dry syrup
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to last measurable concentration (AUC0- tz)
Time frame: up to 34 hours after drug administration
Maximum measured concentration of the analytes in plasma (Cmax)
Time frame: up to 34 hours after drug 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 34 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 34 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)
Time frame: up to 34 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 34 hours after drug administration
Mean residence time of the analyte in the body after po administration (MRTpo)
Time frame: up to 34 hours after drug administration
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 34 hours after last drug administration
Number of patients with clinically significant findings in physical examination
Time frame: up to 34 hours after last drug administration
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Number of patients with clinically significant findings in vital signs
blood pressure, pulse rate, body temperature
Time frame: Up to 34 hours after last drug administration
Number of patients with adverse events
Time frame: Up to 48 hours after last drug administration