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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Hirsutism; Prostate Cancer

Treatments: Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA); Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960310

60111

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)

2

Active Comparator group

Description:

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

Treatment:

Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)