NCT01568281

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Safety
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Anastrozole ODF	Each volunteer will receive a single dose of Anastrozole ODF with water.
DRUG	Arimidex tablet	Each volunteer will receive a single dose of Arimidex tablet with water
DRUG	Anastrozole ODF	Each volunteer will receive a single dose of Anastrozole ODF without water.
DRUG	Arimidex tablet	Each volunteer will receive a single dose of Arimidex tablet with water

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-04-02
• Last updated: 2012-06-25

Locations

1 site across 1 country: Japan