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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics; Safety

Treatments: Drug: Arimidex tablet; Drug: Anastrozole ODF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01568281

D539EC00001

Details and patient eligibility

About

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

Full 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

Enrollment: 58 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 4 patient groups

1

Experimental group

Description:

2 way crossover

Treatment:

Drug: Anastrozole ODF

Drug: Anastrozole ODF

2

Experimental group

Description:

2 way crossover

Treatment:

Drug: Arimidex tablet

Drug: Arimidex tablet

3

Experimental group

Description:

2 way crossover

Treatment:

Drug: Anastrozole ODF

Drug: Anastrozole ODF

4

Experimental group

Description:

2 way crossover

Treatment:

Drug: Arimidex tablet

Drug: Arimidex tablet