Bioequivalence of Bicalutamide New Formulation in Japan

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: ICI176,334-1; Drug: Casodex 80 mg tablet

• Registration Number: NCT01416870
• Lead Sponsor: AstraZeneca

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

Detailed Description

Bioequivalence study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex tablet (80mg)

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-15
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 102

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active 1	ICI176,334-1	34 subjects will receive ICI176,334-1without water
Active 2	ICI176,334-1	34 subjects will receive ICI176,334-1 with water
Active 3	Casodex 80 mg tablet	34 subjects will receive Casodex 80 mg tablet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.