Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions

Randomized, Open-Label, 1-Way Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex (Reference) Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959335

Enrollment

Registered

2009-08-14

Start date

2006-08-31

Completion date

2006-08-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hirsutism, Prostate Cancer

Keywords

treatment

Brief summary

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 fasting conditions.

Interventions

DRUGBicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)

DRUGBicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 63 Years

Healthy volunteers

Yes

Inclusion criteria

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

* Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	11 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026