Status:
TERMINATED
Bioequivalence of Bicalutamide New Formulation in Japan
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01416870
Start Date
July 1 2010
End Date
November 1 2010
Last Update
January 11 2012
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