Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects
NCT ID: NCT01415778
Last Updated: 2012-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2011-08-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Active 1
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
ICI176,334-1
Subject will receive single dose of ICI176,334-1
Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet
Active 2
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
ICI176,334-1
Subject will receive single dose of ICI176,334-1
Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet
Active 3
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
ICI176,334-1
Subject will receive single dose of ICI176,334-1
Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet
Active 4
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
ICI176,334-1
Subject will receive single dose of ICI176,334-1
Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet
Interventions
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ICI176,334-1
Subject will receive single dose of ICI176,334-1
Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
45 Years
MALE
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Other Identifiers
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D6874L00025
Identifier Type: -
Identifier Source: org_study_id
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