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Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829426
First received: January 26, 2009
Last updated: June 18, 2009
Last verified: June 2009
History of Changes
Results First Received: June 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Intervention: Drug: Alprazolam Extended-Release 3 mg Tablets

  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
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Reporting Groups
  Description
Alprazolam (Test) First Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
Xanax® (Reference) First Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period

Participant Flow for 3 periods

 Period 1:   First Intervention
    Alprazolam (Test) First     Xanax® (Reference) First  
STARTED     16     16  
COMPLETED     16     16  
NOT COMPLETED     0     0  

Period 2:   Washout: 7 Days
    Alprazolam (Test) First     Xanax® (Reference) First  
STARTED     16     16  
COMPLETED     15     16  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  

Period 3:   Second Intervention
    Alprazolam (Test) First     Xanax® (Reference) First  
STARTED     15     16  
COMPLETED     15     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Alprazolam (Test) First Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
Xanax® (Reference) First Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
Total Total of all reporting groups

Baseline Measures
    Alprazolam (Test) First     Xanax® (Reference) First     Total  
Number of Participants  
[units: participants]
 		  16     16     32  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     16     16     32  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     3     1     4  
Male     13     15     28  
Race/Ethnicity, Customized  
[units: Participants]
 		     
White     15     12     27  
Black     0     1     1  
Asian     0     1     1  
Native American or Alaskan Native     1     2     3  
Region of Enrollment  
[units: participants]
 		     
United States     16     16     32  



  Outcome Measures
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1.  Primary:   Bioequivalence Based on Cmax   [ Time Frame: Blood samples collected over 72 hour period ]
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2.  Primary:   Bioequivalence Based on AUC0-inf   [ Time Frame: Blood samples collected over 72 hour period ]
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3.  Primary:   Bioequivalence Based on AUC0-t   [ Time Frame: Blood samples collected over 72 hour period ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com


No publications provided


ClinicalTrials.gov Identifier: NCT00829426     History of Changes
Other Study ID Numbers: R05-0166
Study First Received: January 26, 2009
Results First Received: June 18, 2009
Last Updated: June 18, 2009
Health Authority: United States: Institutional Review Board