Bioequivalence of Bicalutamide New Formulation in Japan

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bicalutamide

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