Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects
- Registration Number
- NCT01415778
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.
- Detailed Description
Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
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
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active 3 Casodex 80 mg tablet 12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet Active 4 Casodex 80 mg tablet 12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet Active 1 ICI176,334-1 12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet Active 1 Casodex 80 mg tablet 12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet Active 2 ICI176,334-1 12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet Active 2 Casodex 80 mg tablet 12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet Active 3 ICI176,334-1 12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet Active 4 ICI176,334-1 12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.