Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS. Safety and tolerability were also assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
single dose
5 days
Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.)
Time frame: up to 36 hours after drug administration
Maximum observed plasma concentration (Cmax)
Time frame: up to 36 hours after drug administration
Area under the plasma concentration versus time curve over a given time interval (AUC0-t)
Time frame: up to 36 hours after drug administration
Time to the maximum plasma concentration (tmax)
Time frame: up to 36 hours after drug administration
Apparent oral clearance (CL/F)
Time frame: up to 36 hours after drug administration
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Time frame: up to 36 hours after drug administration
Elimination half-life (t1/2)
Time frame: up to 36 hours after drug administration
Mean residence time (MRT)
Time frame: up to 36 hours after drug administration
Gastric pH measurements
Time frame: up to 12 hours after drug administration
Number of patients with adverse events
Time frame: up to 34 days
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Assessment of tolerability
based on the ability of the subjects to take the medicine as well as occurence of adverse events and abnormal laboratory investigations
Time frame: on the last 1 day of second treatment