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

Phase 1

Completed

• Conditions: Hirsutism; Prostate Cancer
• Interventions: Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA); Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)

• Registration Number: NCT00959335
• Lead Sponsor: Sandoz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)	Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
1	Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)	Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	11 days