Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01415778

D6874L00025

Details and patient eligibility

About

The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.

Full description

Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -

Enrollment: 48 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: Crossover Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Active 1

Experimental group

Description:

12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet

Treatment:

Drug: Casodex 80 mg tablet

Drug: ICI176,334-1

Active 2

Experimental group

Description:

12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet

Treatment:

Drug: Casodex 80 mg tablet

Drug: ICI176,334-1

Active 3

Experimental group

Description:

12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet

Treatment:

Drug: Casodex 80 mg tablet

Drug: ICI176,334-1

Active 4

Experimental group

Description:

12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet

Treatment:

Drug: Casodex 80 mg tablet

Drug: ICI176,334-1