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CompletedNCT01568281Updated Jun 25, 2012

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

A Phase 1 interventional study of Anastrozole ODF and Arimidex tablet in Safety and Pharmacokinetics, sponsored by AstraZeneca. Completed at 1 site in Japan. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-25.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

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

Read the 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

02

Conditions studied

  • Safety
  • Pharmacokinetics

Keywords

  • Bioequivalence
  • pharmacokinetics
  • safety
  • anastrozole
  • Arimidex
  • Japanese
  • healthy subject
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    1

    2 way crossover

    Drug: Anastrozole ODF

  • Experimental
    2

    2 way crossover

    Drug: Arimidex tablet

  • Experimental
    3

    2 way crossover

    Drug: Anastrozole ODF

  • Experimental
    4

    2 way crossover

    Drug: Arimidex tablet

Interventions

  • DrugAnastrozole ODF

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

  • 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 without water.

  • DrugArimidex tablet

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

06

What researchers measure

Primary outcomes

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

    By assessment of AUC and Cmax of anastrozole after a single oral administration of each anastrozole formulation.

    Time frame: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose

Secondary outcomes

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

    By assessment of AUC, MRT, tmax, kel and t1/2 of anastrozole.

    Time frame: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose

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

    By assessment of adverse events, clinical laboratory tests, 12-lead ECG, blood pressure, pulse rate and body temperature.

    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

07

Study locations

1 site
  • Research Site
    Fukuoka, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01568281
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Apr 2, 2012
Start date
Apr 2012
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jun 25, 2012

Study contacts

Eisei Shin, MD
study director · AstraZeneca R&D Japan
Kyoko Matsuguma, MD PhD
principal investigator · Kyushu Clinical Pharmacology Research Clinic
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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