A Study to Compare the Relative Bioavailability of Two 200 Mg Tramadol Hydrochloride Tablet Products Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Labopharm Inc.
ClinicalTrials.gov Identifier:
NCT00834366
First received: January 30, 2009
Last updated: April 25, 2012
Last verified: April 2012
Results First Received: April 6, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Intervention: Drug: Tramadol 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
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
Tramadol HCl 200 mg Film-coated Tablets Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Tramadol HCl 200 mg Uncoated Tablets Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Tramadol HCl 200 mg Film-coated Tablets     Tramadol HCl 200 mg Uncoated Tablets  
STARTED     13     13  
COMPLETED     12     12  
NOT COMPLETED     1     1  
Adverse Event                 1                 1  

Period 2:   Treatment Period 2
    Tramadol HCl 200 mg Film-coated Tablets     Tramadol HCl 200 mg Uncoated Tablets  
STARTED     12     12  
COMPLETED     12     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
Tramadol HCl 200 mg Film-coated Tablets Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Tramadol HCl 200 mg Uncoated Tablets Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Total Total of all reporting groups

Baseline Measures
    Tramadol HCl 200 mg Film-coated Tablets     Tramadol HCl 200 mg Uncoated Tablets     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     13     26  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     6     5     11  
Male     7     8     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   AUC(0-t)   [ Time Frame: 48 hours ]

2.  Primary:   AUC(0-Inf)   [ Time Frame: 48 hours ]

3.  Primary:   Cmax   [ Time Frame: 48 hours ]

4.  Secondary:   Tmax   [ Time Frame: 48 hours ]

5.  Secondary:   t1/2   [ Time Frame: 48 hours ]


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


No publications provided


Responsible Party: Sybil Robertson, Vice President, Regulatory Affairs, Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00834366     History of Changes
Other Study ID Numbers: MDT1-013
Study First Received: January 30, 2009
Results First Received: April 6, 2009
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council