Clinical trial NCT01416870: Bioequivalence of Bicalutamide New Formulation in Japan
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
pharmacokinetics
safety
bicalutamide
Casodex
Japanese
healthy subject
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 102
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: To investigate the bioequivalence of ICI176,334-1 by assessment of Cmax (Maximum Concentration of drug).
timeFrame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
measure: To investigate the bioequivalence of ICI176,334-1 by assessment of AUC (concentration Area Under the Curve).
timeFrame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
measure: To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 (half time) of bicalutamide
timeFrame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
Secondary outcomes:
measure: To assess the safety by assessment of adverse event.
timeFrame: Subjects will be monitored for adverse events prior to treatment and up to 42 -49 days (follow-up) after the last dose.
measure: To assess the safety by assessment of vital signs.
timeFrame: Subjects will be monitored for vital signs prior to treatment and up to 42 -49 days (follow-up) after the last dose.
measure: To assess the safety by assessment of electrocardiograms (ECGs)
timeFrame: Subjects will be monitored for electrocardiograms(ECGs) prior to treatment and up to 42 -49 days (follow-up) after the last dose.
Other outcomes:
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