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The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA) |
|
| 2 | Active Comparator | Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA) | Drug |
| ||
| Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Larouche, M.D. | Anapharm | Principal Investigator |
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| Drug |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D006628 | Hirsutism |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014770 | Virilism |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C053541 | bicalutamide |
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