Status:
COMPLETED
Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects
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 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 -
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 :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01415778
Start Date
August 1 2011
End Date
December 1 2011
Last Update
May 30 2012
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