Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01260896
First received: December 14, 2010
Last updated: January 24, 2011
Last verified: January 2011
Results First Received: January 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Venlafaxine Hydrochloride
Drug: Effexor® XR

  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
Venlafaxine Hydrochloride (Test) First 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
Effexor® XR (Reference) First 150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Venlafaxine Hydrochloride (Test) First     Effexor® XR (Reference) First  
STARTED     12     12  
COMPLETED     10     12  
NOT COMPLETED     2     0  
Withdrawn Due to Emesis                 2                 0  

Period 2:   Washout of 7 Days
    Venlafaxine Hydrochloride (Test) First     Effexor® XR (Reference) First  
STARTED     10     12  
COMPLETED     10     12  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Venlafaxine Hydrochloride (Test) First     Effexor® XR (Reference) First  
STARTED     10     12  
COMPLETED     10     12  
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
Venlafaxine Hydrochloride (Test) First 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
Effexor® XR (Reference) First 150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
    Venlafaxine Hydrochloride (Test) First     Effexor® XR (Reference) First     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     4     4     8  
Male     8     8     16  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     12     12     24  
Region of Enrollment  
[units: participants]
     
Canada     12     12     24  



  Outcome Measures
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1.  Primary:   Cmax of Venlafaxine.   [ Time Frame: Blood samples collected over a 36 hour period. ]

2.  Primary:   AUC0-t of Venlafaxine.   [ Time Frame: Blood samples collected over a 36 hour period. ]

3.  Primary:   AUC0-inf of Venlafaxine.   [ Time Frame: Blood samples collected over a 36 hour period. ]

4.  Secondary:   Cmax of O-Desmethylvenlafaxine.   [ Time Frame: Blood samples collected over a 36 hour period. ]

5.  Secondary:   AUC0-t of O-Desmethylvenlafaxine.   [ Time Frame: Blood samples collected over a 36 hour period. ]

6.  Secondary:   AUC0-inf of O-Desmethylvenlafaxine.   [ Time Frame: Blood samples collected over a 36 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


Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT01260896     History of Changes
Other Study ID Numbers: 02204
Study First Received: December 14, 2010
Results First Received: January 24, 2011
Last Updated: January 24, 2011
Health Authority: Canada: Ethics Review Committee