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

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ClinicalTrials.gov Identifier: NCT00834366
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : June 8, 2009
Last Update Posted : April 30, 2012
Sponsor:
Information provided by:
Labopharm Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Intervention Drug: Tramadol HCl
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Hide Arm/Group Description Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule. Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Period Title: Treatment Period 1
Started 13 13
Completed 12 12
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
Period Title: Treatment Period 2
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets Total
Hide Arm/Group Description Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule. Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule. Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
13
 100.0%
13
 100.0%
26.0
>=65 years
0
   0.0%
0
   0.0%
0.0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
6
  46.2%
5
  38.5%
11.0
Male
7
  53.8%
8
  61.5%
15.0
1.Primary Outcome
Title AUC(0-t)
Hide Description Area under plasma concentration versus time curve to the last measurable concentration. Unit is ng.h/mL. h=hours.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Hide Arm/Group Description:
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
5181  (1338) 5010  (1176)
2.Primary Outcome
Title AUC(0-Inf)
Hide Description Area under plasma concentration versus time curve extrapolated to infinity. Unit is ng.h/mL. h=hour.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Hide Arm/Group Description:
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
5328  (1421) 5175  (1241)
3.Primary Outcome
Title Cmax
Hide Description Maximum plasma concentration
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Hide Arm/Group Description:
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
218  (49) 209  (45)
4.Secondary Outcome
Title Tmax
Hide Description Time to the maximum concentration
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Hide Arm/Group Description:
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: hours
6
(3 to 12)
6
(3 to 10)
5.Secondary Outcome
Title t1/2
Hide Description Apparent terminal elimination half-life
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Hide Arm/Group Description:
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: hours
7.08  (1.45) 7.38  (1.76)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Hide Arm/Group Description Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule. Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
All-Cause Mortality
Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tramadol HCl 200 mg Film-coated Tablets Tramadol HCl 200 mg Uncoated Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/25 (36.00%)      10/25 (40.00%)    
Gastrointestinal disorders     
Nausea *  4/25 (16.00%)  4 1/25 (4.00%)  2
Nervous system disorders     
Drowsiness *  1/25 (4.00%)  1 5/25 (20.00%)  5
Dizziness *  7/25 (28.00%)  9 6/25 (24.00%)  6
*
Indicates events were collected by non-systematic assessment
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.
If a publication based on the results of this study is envisaged, approval from the sponsor will be obtained and a draft manuscript will be submitted to the sponsor for scrutiny and comment.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
Phone: 1 450 686 1017
Layout table for additonal information
Responsible Party: Sybil Robertson, Vice President, Regulatory Affairs, Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00834366     History of Changes
Other Study ID Numbers: MDT1-013
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: April 6, 2009
Results First Posted: June 8, 2009
Last Update Posted: April 30, 2012