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15 mg Mirtazapine Orally Disintegrating Tablets, Fasting

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835575
First received: January 30, 2009
Last updated: September 1, 2009
Last verified: September 2009
History of Changes
Results First Received: July 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Mirtazapine 15 mg (Orally Disintegrating) Tablets
Drug: REMERON SolTab® 15 mg Orally Disintegrating 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
Test (Mirtazapine) First 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
Reference (Remeron®) First 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.

Participant Flow for 3 periods

 Period 1:   First Intervention
    Test (Mirtazapine) First     Reference (Remeron®) First  
STARTED     16     16  
COMPLETED     16     16  
NOT COMPLETED     0     0  

Period 2:   Washout of 14 Days
    Test (Mirtazapine) First     Reference (Remeron®) First  
STARTED     16     16  
COMPLETED     15     16  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  

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



  Baseline Characteristics
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Reporting Groups
  Description
Test (Mirtazapine) First 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
Reference (Remeron®) First 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
    Test (Mirtazapine) First     Reference (Remeron®) 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     4     4     8  
Male     12     12     24  
Race/Ethnicity, Customized  
[units: participants]
 		     
Black     0     1     1  
White     16     15     31  
Region of Enrollment  
[units: participants]
 		     
United States     16     16     32  



  Outcome Measures
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1.  Primary:   Cmax (Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 120 hour period. ]
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2.  Primary:   AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 120 hour period. ]
  Show Outcome Measure 2

3.  Primary:   AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 120 hour period. ]
  Show Outcome Measure 3


  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
No text entered.  


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: NCT00835575     History of Changes
Other Study ID Numbers: R03-338
Study First Received: January 30, 2009
Results First Received: July 2, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board