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

Phase 1

Completed

• Conditions: Safety; Pharmacokinetics
• Interventions: Drug: Anastrozole ODF; Drug: Arimidex tablet

• Registration Number: NCT01568281
• Lead Sponsor: AstraZeneca

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2012-03-29
• Study Start: 2012-04
• Study First Posted: 2012-04-02
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Anastrozole ODF	2 way crossover
2	Arimidex tablet	2 way crossover
3	Anastrozole ODF	2 way crossover
4	Arimidex tablet	2 way crossover

Primary Outcome Measures

Name	Time	Method
Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet.	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 Outcome Measures

Name	Time	Method
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	By assessment of AUC, MRT, tmax, kel and t1/2 of anastrozole.
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	By assessment of adverse events, clinical laboratory tests, 12-lead ECG, blood pressure, pulse rate and body temperature.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka, Japan