Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects
Bioequivalence Study of ICI176,334-1 in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex 80 mg Tablet -
1 other identifier
interventional
48
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Aug 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 11, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 30, 2012
May 1, 2012
3 months
August 11, 2011
May 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To investigate the bioequivalence of ICI176,334-1 by assessment of maximum plasma concentration (Cmax)
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 time to Cmax (tmax)
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 area under the plasma concentration curve (AUC)
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 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
Screening day up to 35 to 42 days (follow-up)
To assess the safety by assessment of vital signs
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
To assess the safety by assessment of electrocardiograms (ECGs)
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
Study Arms (4)
Active 1
EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Active 2
EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Active 3
EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Active 4
EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Interventions
Subject will receive single dose of Casodex 80 mg tablet
Eligibility Criteria
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
- AstraZenecalead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2011
First Posted
August 12, 2011
Study Start
August 1, 2011
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
May 30, 2012
Record last verified: 2012-05