The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.
Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Subject will receive single dose of ICI176,334-1
Subject will receive single dose of Casodex 80 mg tablet
To investigate the bioequivalence of ICI176,334-1 by assessment of maximum plasma concentration (Cmax)
Time frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of time to Cmax (tmax)
Time frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of area under the plasma concentration curve (AUC)
Time frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 of bicalutamide
Time frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To assess the safety by assessment of adverse event
Time frame: Screening day up to 35 to 42 days (follow-up)
To assess the safety by assessment of vital signs
Time frame: Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
To assess the safety by assessment of electrocardiograms (ECGs)
Time frame: Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
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