To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Maximum concentration of the analyte in plasma (Cmax)
Time frame: Up to 48 hours after drug administration
Time to reach maximum concentration of the analyte in plasma (tmax)
Time frame: Up to 48 hours after drug administration
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Time frame: Up to 48 hours after drug administration
Area under the concentration-time curve of the analyte in plasma at different time points (AUC)
Time frame: Up to 48 hours after drug administration
Total mean residence time of the analyte in the body (MRTtot)
Time frame: Up to 48 hours after drug administration
Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f)
Time frame: Up to 48 hours after drug administration
Apparent volume of distribution of the analyte during the terminal phase (Vz/f)
Time frame: Up to 48 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)
Time frame: Up to 48 hours after drug administration
Number of patients with adverse events
Time frame: Up to 48 hours after last drug administration
Global clinical assessment by the investigator
Time frame: Day 3 after last drug administration
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