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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568281
• Other study ID #: D539EC00001
• Status: Completed
• Phase: Phase 1
• First received: March 28, 2012
• Last updated: June 22, 2012
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics
• Safety

Intervention

Drug:
• Anastrozole ODF
Each volunteer will receive a single dose of Anastrozole ODF with water.
• Arimidex tablet
Each volunteer will receive a single dose of Arimidex tablet with water
• Anastrozole ODF
Each volunteer will receive a single dose of Anastrozole ODF without water.
• Arimidex tablet
Each volunteer will receive a single dose of Arimidex tablet with water

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes