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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01568281
First received: March 28, 2012
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Safety
Pharmacokinetics
Drug: Anastrozole ODF
Drug: Arimidex tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    By assessment of AUC and Cmax of anastrozole after a single oral administration of each anastrozole formulation.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    By assessment of AUC, MRT, tmax, kel and t1/2 of anastrozole.

  • 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 ] [ Designated as safety issue: Yes ]
    By assessment of adverse events, clinical laboratory tests, 12-lead ECG, blood pressure, pulse rate and body temperature.


Enrollment: 58
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2 way crossover
Drug: Anastrozole ODF
Each volunteer will receive a single dose of Anastrozole ODF with water.
Experimental: 2
2 way crossover
Drug: Arimidex tablet
Each volunteer will receive a single dose of Arimidex tablet with water
Experimental: 3
2 way crossover
Drug: Anastrozole ODF
Each volunteer will receive a single dose of Anastrozole ODF without water.
Experimental: 4
2 way crossover
Drug: Arimidex tablet
Each volunteer will receive a single dose of Arimidex tablet with water

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568281

Locations
Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eisei Shin, MD AstraZeneca R&D Japan
Principal Investigator: Kyoko Matsuguma, MD PhD Kyushu Clinical Pharmacology Research Clinic
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01568281     History of Changes
Other Study ID Numbers: D539EC00001
Study First Received: March 28, 2012
Last Updated: June 22, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Bioequivalence
pharmacokinetics
safety
anastrozole
Arimidex
Japanese
healthy subject

Additional relevant MeSH terms:
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014