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A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.
ClinicalTrials.gov Identifier:
NCT01121900
First received: May 10, 2010
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
Results First Received: June 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Intervention: Drug: Trazodone HCl

  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
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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 (Trazodone Contramid® OAD) First

Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.

IR = Immediate Release.
Reference (Trazodone IR [Apotex Corp.]) First

Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.

IR = Immediate Release.

Participant Flow for 3 periods

 Period 1:   First Intervention Period
    Test (Trazodone Contramid® OAD) First     Reference (Trazodone IR [Apotex Corp.]) First  
STARTED     13     13  
COMPLETED     12     12  
NOT COMPLETED     1     1  
Adverse Event                 1                 1  

Period 2:   Washout Period of 7 Days
    Test (Trazodone Contramid® OAD) First     Reference (Trazodone IR [Apotex Corp.]) First  
STARTED     12     12  
COMPLETED     12     11  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  

Period 3:   Second Intervention Period
    Test (Trazodone Contramid® OAD) First     Reference (Trazodone IR [Apotex Corp.]) First  
STARTED     12     11  
COMPLETED     12     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive Test first and Reference first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  26  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     26  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  25.2  ± 10.88  
Gender  
[units: participants]
 		 
Female     16  
Male     10  
Region of Enrollment  
[units: participants]
 		 
South Africa     26  



  Outcome Measures
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1.  Primary:   Bioequivalence Based Cmax   [ Time Frame: 68 hours ]
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2.  Primary:   Bioequivalence Based on AUC(0-tlast)   [ Time Frame: 68 hours ]
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3.  Primary:   Bioequivalence Based on AUC(0-∞)   [ Time Frame: 68 hours ]
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4.  Secondary:   Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)]   [ Time Frame: 24 hours ]
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5.  Secondary:   Time to Maximum Plasma Concentration (Tmax)   [ Time Frame: 68 hours ]
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6.  Secondary:   Apparent Terminal Elimination Rate Constant (λz)   [ Time Frame: 68 hours ]
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7.  Secondary:   Apparent Terminal Half-life (t½.z)   [ Time Frame: 68 hours ]
  Show Outcome Measure 7


  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: Director of Regulatory Affairs
Organization: Labopharm Inc.
phone: 1 450 686 1017


No publications provided


Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT01121900     History of Changes
Other Study ID Numbers: 04ACL1-010
Study First Received: May 10, 2010
Results First Received: June 22, 2010
Last Updated: April 24, 2012
Health Authority: South Africa: Medicines Control Council