Bioequivalence study comparing Arimidex tablet and anastrozole ODF in Japanese healthy male subjects
Study identifier:D539EC00001
ClinicalTrials.gov identifier:NCT01568281
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Safety
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Anastrozole ODF, Arimidex tablet
Sex
Male
Actual Enrollment
58
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 30 Apr 2012
Primary Completion Date: 30 Jun 2012
Study Completion Date: 30 Jun 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Fukuoka, Fukuoka, Japan
| Arms | Assigned Interventions |
|---|---|
| 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 with water. |
| Experimental: 2 2 way crossover | Drug: Arimidex tablet Each volunteer will receive a single dose of Arimidex tablet with water 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 with water. |
| Experimental: 4 2 way crossover | Drug: Arimidex tablet Each volunteer will receive a single dose of Arimidex tablet with water Drug: Arimidex tablet Each volunteer will receive a single dose of Arimidex tablet with water |
Contacts
Investigators
Principal Investigator
Eisei Shin
AstraZeneca R&D Japan
