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A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00834288
First Posted: February 3, 2009
Last Update Posted: April 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Labopharm Inc.
Results First Submitted: April 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Healthy Subjects
Pharmacokinetics
Bioavailability
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
Test (Tramadol HCl OAD 200 mg) First 1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First

1 x 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.

IR = Immediate Release.


Participant Flow for 2 periods

Period 1:   Treatment Phase I
    Test (Tramadol HCl OAD 200 mg) First   Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First
STARTED   13   13 
COMPLETED   13   13 
NOT COMPLETED   0   0 

Period 2:   Treatment Phase II
    Test (Tramadol HCl OAD 200 mg) First   Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First
STARTED   13   13 
COMPLETED   13   13 
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
Test (Tramadol HCl OAD 200 mg) First 1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First 1 x 50 mg Tramadol HCl IR (Ultram®) Tablet 6-Hourly reference product dosed in first period followed by Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II). IR = Immediate Release.
Total Total of all reporting groups

Baseline Measures
   Test (Tramadol HCl OAD 200 mg) First   Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First   Total 
Overall Participants Analyzed 
[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   2   2   4 
Male   11   11   22 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss)   [ Time Frame: 24 hours (day 5) ]

2.  Secondary:   Maximum Plasma Concentration at Steady State(Cmax,ss)   [ Time Frame: 24 hours (day 5) ]

3.  Secondary:   Minimum Plasma Concentration at Steady State(Cmin,ss)   [ Time Frame: 24 hours (day 5) ]

4.  Secondary:   Time to Peak Exposure (Tmax)   [ Time Frame: 24 hours (day 5) ]

5.  Secondary:   Percentage Peak-trough Fluctuation (% PTF)   [ Time Frame: 24 hours (day 5) ]

6.  Secondary:   Percentage Swing   [ Time Frame: 24 hours (day 5) ]

7.  Secondary:   Half-value Duration (HVD)   [ Time Frame: 24 hours (day 5) ]

8.  Secondary:   Plateau Time (T75%Cmax)   [ Time Frame: 24 hours (day 5) ]


  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


Publications of Results:

Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00834288     History of Changes
Other Study ID Numbers: MDT1-009
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: April 8, 2009
Results First Posted: October 19, 2009
Last Update Posted: April 27, 2012