NCT00960310

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Jun 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
Last Updated

March 28, 2017

Status Verified

August 1, 2009

Enrollment Period

Same day

First QC Date

August 13, 2009

Last Update Submit

March 27, 2017

Conditions

Prostate CancerHirsutism

Keywords

Treatment

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    11 days

Study Arms (2)

1

EXPERIMENTAL

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

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

2

ACTIVE COMPARATOR

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

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

Interventions

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

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic NeoplasmsHirsutism

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Larouche, M.D.

    Anapharm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 17, 2009

Study Start

June 1, 2006

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

March 28, 2017

Record last verified: 2009-08