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Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT01155102
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

June 28, 2010
July 1, 2010
January 23, 2018
April 2006
May 2006   (Final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 31 days ]
Same as current
Complete list of historical versions of study NCT01155102 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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 Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Same as current
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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01155102
ANAS-T1-PVFS-1
No
Not Provided
Not Provided
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
West-Ward Pharmaceutical
January 2018

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