The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects
Bioequivalence study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex tablet (80mg)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
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 Cmax (Maximum Concentration of drug).
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 AUC (concentration Area Under the Curve).
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 (half time) 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: Subjects will be monitored for adverse events prior to treatment and up to 42 -49 days (follow-up) after the last dose.
To assess the safety by assessment of vital signs.
Time frame: Subjects will be monitored for vital signs prior to treatment and up to 42 -49 days (follow-up) after the last dose.
To assess the safety by assessment of electrocardiograms (ECGs)
Time frame: Subjects will be monitored for electrocardiograms(ECGs) prior to treatment and up to 42 -49 days (follow-up) after the last dose.
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