Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01155102
First received: June 28, 2010
Last updated: October 6, 2010
Last verified: October 2010

June 28, 2010
October 6, 2010
April 2006
May 2006   (final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 31 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01155102 on ClinicalTrials.gov Archive Site
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Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fasting Conditions

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Anastrozole
1 mg tablet
Other Name: ARIMIDEX
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01155102
ANAS-T1-PVFS-1
No
Elizabeth Ernst, Director, Drug Regulatory and Medical Affairs, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: Dennis Morrison, D.O. Bio-Kinetic Clinical Applications
Roxane Laboratories
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP