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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active 1 | Experimental | 8 subjects will receive ICI176,334-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICI176,334-1 | Drug | Subject will receive single dose of ICI176,334-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva. | 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. | Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety by assessment of adverse event. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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). | 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. |