Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.

Detailed Description
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Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -

Official Title
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Bioequivalence Study of ICI176,334-1 in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex 80 mg Tablet -

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active 1<br>12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet | Drug: ICI176,334-1<br>* Subject will receive single dose of ICI176,334-1<br>Drug: Casodex 80 mg tablet<br>* Subject will receive single dose of Casodex 80 mg tablet<br>|
| Experimental: Active 2<br>12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet | Drug: ICI176,334-1<br>* Subject will receive single dose of ICI176,334-1<br>Drug: Casodex 80 mg tablet<br>* Subject will receive single dose of Casodex 80 mg tablet<br>|
| Experimental: Active 3<br>12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet | Drug: ICI176,334-1<br>* Subject will receive single dose of ICI176,334-1<br>Drug: Casodex 80 mg tablet<br>* Subject will receive single dose of Casodex 80 mg tablet<br>|
| Experimental: Active 4<br>12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet | Drug: ICI176,334-1<br>* Subject will receive single dose of ICI176,334-1<br>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 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 Outcome Measures

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

 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