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

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

Detailed Description
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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

Official Title
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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

Conditions
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Safety, Pharmacokinetics

Intervention / Treatment
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* Drug: Anastrozole ODF
* Drug: Arimidex tablet
* Drug: Anastrozole ODF
* Drug: Arimidex tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2 way crossover | Drug: Anastrozole ODF<br>* Each volunteer will receive a single dose of Anastrozole ODF with water.<br>|
| Experimental: 2<br>2 way crossover | Drug: Arimidex tablet<br>* Each volunteer will receive a single dose of Arimidex tablet with water<br>|
| Experimental: 3<br>2 way crossover | Drug: Anastrozole ODF<br>* Each volunteer will receive a single dose of Anastrozole ODF without water.<br>|
| Experimental: 4<br>2 way crossover | Drug: Arimidex tablet<br>* Each volunteer will receive a single dose of Arimidex tablet with water<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, pharmacokinetics, safety, anastrozole, Arimidex, Japanese, healthy subject