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Bioequivalency Study of Anastrozole 1 mg Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01155089
First received: June 28, 2010
Last updated: October 6, 2010
Last verified: October 2010
History of Changes
  Purpose

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


Condition Intervention
Breast Cancer
 Drug: Anastrozole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fed Conditions

Resource links provided by NLM:

Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 31 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Anastrozole
    1 mg tablet
    Other Name: ARIMIDEX
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155089

Locations
United States, Missouri
Bio-Kinetic Clinical Applications
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Dennis Morrison, D.O. Bio-Kinetic Clincial Applications
  More Information

No publications provided

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01155089     History of Changes
Other Study ID Numbers: ANAS-T1-PVFD-1
Study First Received: June 28, 2010
Last Updated: October 6, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013