Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF IIb
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
Time frame: predose, up to 24 hours
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: predose, up to 264 hours
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: predose, up to 264 hours
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: predose, up to 264 hours
AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: predose, up to 264 hours
C24 (plasma concentration of the analyte 24 hours after dosing)
Time frame: predose, up to 264 hours
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: predose, up to 264 hours
λz (terminal rate constant in plasma)
Time frame: predose, up to 264 hours
t1/2 (terminal half-life of the analyte in plasma)
Time frame: predose, up to 264 hours
MRTpo (mean residence time of the analyte in the body after po administration)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: predose, up to 264 hours
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: predose, up to 264 hours
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: predose, up to 264 hours
Changes in Dipeptidyl-peptidase-IV (DPP-IV) activity in plasma
Time frame: predose, up to 264 hours
Changes in plasma glucose levels
Time frame: predose, up to 264 hours
Number of patients with adverse events
Time frame: up to 18 days following last drug administration
Number of patients with abnormal findings in physical examination
Time frame: up to 18 days following last drug administration
Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
Time frame: up to 18 days following last drug administration
Number of patients with abnormal changes 12-lead ECG (electrocardiogram)
Time frame: up to 18 days following last drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 18 days following last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 18 days following last drug administration