The purpose of this study is to investigate the presence or absence of oral mucosal absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects
Oral mucosal absorption study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Subject will receive single dose of ICI176,334-1
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva.
Time frame: Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma.
Time frame: Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
To assess the safety by assessment of adverse event.
Time frame: Subjects will be monitored for adverse events prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
To assess the safety by assessment of vital signs.
Time frame: Subjects will be monitored for vital signs prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
To assess the safety by assessment of electrocardiograms (ECGs).
Time frame: Subjects will be monitored for electrocardiograms (ECGs) prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.