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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01568281

Enrollment

Registered

2012-04-02

Start date

2012-04-30

Completion date

2012-06-30

Last updated

2012-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics, Safety

Keywords

Bioequivalence, pharmacokinetics, safety, anastrozole, Arimidex, Japanese, healthy subject

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

Interventions

DRUGArimidex tablet

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

DRUGAnastrozole ODF

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet.	Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose	By assessment of AUC and Cmax of anastrozole after a single oral administration of each anastrozole formulation.

Secondary

Measure	Time frame	Description
Evaluation of the pharmacokinetic properties of Arimidex tablet and anastrozole ODF following a single oral dose.	Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose	By assessment of AUC, MRT, tmax, kel and t1/2 of anastrozole.
Evaluation of the safety and tolerability of Anastrozole ODF 1 mg.	Safety variables are measured prior to treatment and up to 14 to 17 days (follow-up) after the last dose. Subjects will be monitored throughout the study for adverse events	By assessment of adverse events, clinical laboratory tests, 12-lead ECG, blood pressure, pulse rate and body temperature.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026