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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

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ClinicalTrials.gov Identifier: NCT00960310
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
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 fed conditions.

Condition or disease Intervention/treatment Phase
Prostate Cancer Hirsutism Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA) Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Fed Conditions.
Study Start Date : June 2006
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Active Comparator: 2
Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 11 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960310


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Richard Larouche, M.D. Anapharm

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00960310     History of Changes
Other Study ID Numbers: 60111
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: August 2009

Keywords provided by Sandoz:
Treatment

Additional relevant MeSH terms:
Hirsutism
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents