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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active 1 | Experimental | 34 subjects will receive ICI176,334-1without water |
|
| Active 2 | Experimental | 34 subjects will receive ICI176,334-1 with water |
|
| Active 3 | Experimental | 34 subjects will receive Casodex 80 mg tablet |
|
| 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 bioequivalence of ICI176,334-1 by assessment of Cmax (Maximum Concentration of drug). | 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). | 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 | Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period |
| 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 42 -49 days (follow-up) after the last dose. | |
| To assess the safety by assessment of vital signs. | Subjects will be monitored for vital signs prior to treatment and up to 42 -49 days (follow-up) after the last dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Casodex 80 mg tablet |
| Drug |
Subject will receive single dose of Casodex 80 mg tablet |
|
| To assess the safety by assessment of electrocardiograms (ECGs) | Subjects will be monitored for electrocardiograms(ECGs) prior to treatment and up to 42 -49 days (follow-up) after the last dose. |