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

NCT ID: NCT00960310

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Prostate Cancer Hirsutism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

2

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Sandoz Inc.

Principal Investigators

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Richard Larouche, M.D.

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Other Identifiers

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60111

Identifier Type: -

Identifier Source: org_study_id

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