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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Safety
• Intervention / Treatment: Drug: Anastrozole ODF; Drug: Anastrozole ODF; Drug: Arimidex tablet

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

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 2 way crossover	Drug: Anastrozole ODF; Each volunteer will receive a single dose of Anastrozole ODF with water.; Drug: Anastrozole ODF; Each volunteer will receive a single dose of Anastrozole ODF without 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 with water.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Eisei Shin, MD, AstraZeneca R&D Japan; Principal Investigator: Kyoko Matsuguma, MD PhD, Kyushu Clinical Pharmacology Research Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 28, 2012
• First Submitted That Met QC Criteria: March 29, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Estimate): June 25, 2012
• Last Update Submitted That Met QC Criteria: June 22, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: safety; Bioequivalence; pharmacokinetics; Japanese; anastrozole; healthy subject; Arimidex
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole
• Other Study ID Numbers: D539EC00001