Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male Subjects

NCT ID: NCT01568281

Last Updated: 2012-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-06-30

Brief Summary

This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation.

Detailed Description

A Randomised, Open label, Single centre, 2 way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects

Conditions

Safety; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

2 way crossover

Group Type: EXPERIMENTAL

Anastrozole ODF

Intervention Type: DRUG

Each volunteer will receive a single dose of Anastrozole ODF with water.

2

2 way crossover

Group Type: EXPERIMENTAL

Arimidex tablet

Intervention Type: DRUG

Each volunteer will receive a single dose of Arimidex tablet with water

3

2 way crossover

Group Type: EXPERIMENTAL

Anastrozole ODF

Intervention Type: DRUG

Each volunteer will receive a single dose of Anastrozole ODF without water.

4

2 way crossover

Group Type: EXPERIMENTAL

Arimidex tablet

Intervention Type: DRUG

Each volunteer will receive a single dose of Arimidex tablet with water

Interventions

Anastrozole ODF

Each volunteer will receive a single dose of Anastrozole ODF with water.

Intervention Type: DRUG

Arimidex tablet

Each volunteer will receive a single dose of Arimidex tablet with water

Intervention Type: DRUG

Anastrozole ODF

Each volunteer will receive a single dose of Anastrozole ODF without water.

Intervention Type: DRUG

Arimidex tablet

Each volunteer will receive a single dose of Arimidex tablet with water

Intervention Type: DRUG

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 18 and 27 kg/m2

Exclusion Criteria

• History of any clinically significant disease or disorder
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness, medical/surgical procedure or trauma
• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eisei Shin, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D Japan

Kyoko Matsuguma, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Kyushu Clinical Pharmacology Research Clinic

Locations

Research Site

Fukuoka, Fukuoka, Japan

Countries

Japan

Other Identifiers

D539EC00001

Identifier Type: -

Identifier Source: org_study_id