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

Prostate Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959335
• Other study ID #: 60110
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2009
• Last updated: March 27, 2017
• Start date: August 2006
• Est. completion date: August 2006

Study information

• Verified date: March 2017
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 63 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hirsutism
• Prostate Cancer

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on AUC and Cmax		11 days