Bioequivalence of Bicalutamide New Formulation in Japan

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: ICI176,334-1; Drug: Casodex 80 mg tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01416870

D6874L00012

Details and patient eligibility

About

The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects

Full 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)

Enrollment: 102 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

Active 1

Experimental group

Description:

34 subjects will receive ICI176,334-1without water

Treatment:

Drug: ICI176,334-1

Active 2

Experimental group

Description:

34 subjects will receive ICI176,334-1 with water

Treatment:

Drug: ICI176,334-1

Active 3

Experimental group

Description:

34 subjects will receive Casodex 80 mg tablet

Treatment:

Drug: Casodex 80 mg tablet