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Completed

NCT Number: NCT01568281

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

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

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Key information

Conditions

Safety Pharmacokinetics

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Fukuoka, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole ODF

Drug

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

Arimidex tablet

Drug

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

Primary outcomes

  1. Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet.

    Time frame: 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 outcomes

  1. Evaluation of the pharmacokinetic properties of Arimidex tablet and anastrozole ODF following a single oral dose.

    Time frame: 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.

  2. Evaluation of the safety and tolerability of Anastrozole ODF 1 mg.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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