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OpenTrials
Completed

NCT Number: NCT01155089

Bioequivalency Study of Anastrozole 1 mg Under Fed Conditions

The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fed conditions

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bio-Kinetic Clinical Applications

Springfield, Missouri, 65802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion criteria

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to anastrozole or any comparable or similar product.

Treatment and study plan

Anastrozole

Drug

1 mg tablet

Other names: ARIMIDEX

Primary outcomes

  1. bioequivalence determined by statistical comparison Cmax

    Time frame: 31 days

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fed Conditions

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jul 1, 2010
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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