Bioequivalence of Bicalutamide New Formulation in Japan

Study Overview
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Brief Summary
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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
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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)

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: ICI176,334-1
* Drug: Casodex 80 mg tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active 1<br>34 subjects will receive ICI176,334-1without water | Drug: ICI176,334-1<br>* Subject will receive single dose of ICI176,334-1<br>|
| Experimental: Active 2<br>34 subjects will receive ICI176,334-1 with water | Drug: ICI176,334-1<br>* Subject will receive single dose of ICI176,334-1<br>|
| Experimental: Active 3<br>34 subjects will receive Casodex 80 mg tablet | Drug: Casodex 80 mg tablet<br>* Subject will receive single dose of Casodex 80 mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, pharmacokinetics, safety, bicalutamide, Casodex, Japanese, healthy subject