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Anastrozole 1 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01182181
First received: August 12, 2010
Last updated: October 15, 2010
Last verified: October 2010
Results First Received: October 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Anastrozole (Teva Pharmaceuticals USA)
Drug: Anastrozole (Arimidex®)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Anastrazole (Test) First 1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
Arimidex® (Reference) First 1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Anastrazole (Test) First     Arimidex® (Reference) First  
STARTED     11     11  
COMPLETED     10     11  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  

Period 2:   Washout of 21 Days
    Anastrazole (Test) First     Arimidex® (Reference) First  
STARTED     10     11  
COMPLETED     10     10  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  

Period 3:   Second Intervention
    Anastrazole (Test) First     Arimidex® (Reference) First  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Anastrazole (Test) First 1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
Arimidex® (Reference) First 1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
    Anastrazole (Test) First     Arimidex® (Reference) First     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     11     21  
>=65 years     1     0     1  
Gender  
[units: participants]
     
Female     11     11     22  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     10     11     21  
Black     1     0     1  
Region of Enrollment  
[units: participants]
     
Canada     11     11     22  



  Outcome Measures
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1.  Primary:   Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 72 hour period. ]

2.  Primary:   AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 72 hour period. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Associate Director, Biopharmaceutics
Organization: TEVA Pharmaceuticals, USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com


No publications provided


ClinicalTrials.gov Identifier: NCT01182181     History of Changes
Other Study ID Numbers: 2005-1042
Study First Received: August 12, 2010
Results First Received: October 15, 2010
Last Updated: October 15, 2010
Health Authority: Canada: Ethics Review Committee