NCT01416870

Brief Summary

The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
102

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2010

Status
terminated

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

July 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

August 12, 2011

Last Update Submit

January 10, 2012

Conditions

Healthy

Keywords

BioequivalencepharmacokineticssafetybicalutamideCasodexJapanesehealthy subject

Outcome Measures

Primary Outcomes (3)

  • To investigate the bioequivalence of ICI176,334-1 by assessment of Cmax (Maximum Concentration of drug).

    Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period

  • To investigate the bioequivalence of ICI176,334-1 by assessment of AUC (concentration Area Under the Curve).

    Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period

  • To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 (half time) of bicalutamide

    Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period

Secondary Outcomes (3)

  • To assess the safety by assessment of adverse event.

    Subjects will be monitored for adverse events prior to treatment and up to 42 -49 days (follow-up) after the last dose.

  • To assess the safety by assessment of vital signs.

    Subjects will be monitored for vital signs prior to treatment and up to 42 -49 days (follow-up) after the last dose.

  • To assess the safety by assessment of electrocardiograms (ECGs)

    Subjects will be monitored for electrocardiograms(ECGs) prior to treatment and up to 42 -49 days (follow-up) after the last dose.

Study Arms (3)

Active 1

EXPERIMENTAL

34 subjects will receive ICI176,334-1without water

Drug: ICI176,334-1

Active 2

EXPERIMENTAL

34 subjects will receive ICI176,334-1 with water

Drug: ICI176,334-1

Active 3

EXPERIMENTAL

34 subjects will receive Casodex 80 mg tablet

Drug: Casodex 80 mg tablet

Interventions

ICI176,334-1DRUG

Subject will receive single dose of ICI176,334-1

Active 1Active 2
Casodex 80 mg tabletDRUG

Subject will receive single dose of Casodex 80 mg tablet

Active 3

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Japanese healthy male subjects aged 20 to 45 years
  • Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
  • Have a body mass index (BMI) between 17 and 27 kg/m2
  • Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)

You may not qualify if:

  • Presence of any disease under medical treatment
  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
  • Presence of any infectious disease, such as bacteria, virus and fungus
  • Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
  • Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

bicalutamideTablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

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

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 15, 2011

Study Start

July 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

January 11, 2012

Record last verified: 2012-01