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

NCT01568281 | Completed Phase 1

• 1 other identifier: D539EC00001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety; Pharmacokinetics

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (2)

• 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

• 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

Study Arms (4)

1

EXPERIMENTAL

2 way crossover

Drug: Anastrozole ODF

2

EXPERIMENTAL

2 way crossover

Drug: Arimidex tablet

3

EXPERIMENTAL

2 way crossover

Drug: Anastrozole ODF

4

EXPERIMENTAL

2 way crossover

Drug: Arimidex tablet

Interventions

Anastrozole ODF DRUG

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

1

Arimidex tablet DRUG

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

2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Fukuoka, Fukuoka, Japan

Location

MeSH Terms

Interventions

Anastrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eisei Shin, MD

  AstraZeneca R&D Japan

  STUDY DIRECTOR

• Kyoko Matsuguma, MD PhD

  Kyushu Clinical Pharmacology Research Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 2, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 25, 2012

Record last verified: 2012-06

Locations

JP (1)