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

NCT01568281 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2012-06-25

No results posted yet for this study

Summary

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

Conditions

  • Safety
  • Pharmacokinetics

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Eisei Shin, MD · AstraZeneca R&D Japan

  • Kyoko Matsuguma, MD PhD · Kyushu Clinical Pharmacology Research Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01568281 on ClinicalTrials.gov