This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
70
Unnamed facility
Fukuoka, Fukuoka, Japan
Area Under the Concentration-Time (AUC)
Time frame: Day1-71
Maximum observed serum concentration (Cmax)
Time frame: Day1-71
Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration
Time frame: Day1-71
Area under the concentration-time curve (AUC) from 0 to infinity
Time frame: Day1-71
Time to reach the peak concentration (tmax)
Time frame: Day1-71
Mean residence time (MRT) from 0 to final sampling time point
Time frame: Day1-71
Mean residence time (MRT) from 0 to infinity
Time frame: Day1-71
elimination rate constant (kel)
Time frame: Day1-71
Elimination half life (t1/2)
Time frame: Day1-71
Clearance (CL)
Time frame: Day1-71
Incidence of adverse events
Time frame: Day1-71
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