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Trial record 57 of 451 for:    TRAMADOL

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

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ClinicalTrials.gov Identifier: NCT00834288
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : October 19, 2009
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.

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
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test (Tramadol HCl OAD 200 mg) First Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First
Hide Arm/Group Description 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).

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.

Period Title: Treatment Phase I
Started 13 13
Completed 13 13
Not Completed 0 0
Period Title: Treatment Phase II
Started 13 13
Completed 13 13
Not Completed 0 0
Arm/Group Title Test (Tramadol HCl OAD 200 mg) First Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First Total
Hide Arm/Group Description 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). 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 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
2
  15.4%
2
  15.4%
4.0
Male
11
  84.6%
11
  84.6%
22.0
1.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss)
Hide Description

Area under the plasma concentration versus time data pairs over 24 hours (24h) at steady state, on day 5.

ss = steady state. AUCss is also known as AUCtau.

Time Frame 24 hours (day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Hide Arm/Group Description:
Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence and the treatment period 2 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence.
Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence and the treatment period 2 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
5991  (1330) 6399  (1766)
2.Secondary Outcome
Title Maximum Plasma Concentration at Steady State(Cmax,ss)
Hide Description Maximum plasma concentration over 24 hours (24h) at steady state, on day 5. ss = steady state.
Time Frame 24 hours (day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Hide Arm/Group Description:
Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence and the treatment period 2 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence.
Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence and the treatment period 2 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
345  (73) 423  (97)
3.Secondary Outcome
Title Minimum Plasma Concentration at Steady State(Cmin,ss)
Hide Description Minimum plasma concentration over 24 hours (24h) at steady state on day 5. ss = steady state.
Time Frame 24 hours (day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Hide Arm/Group Description:
Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence and the treatment period 2 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence.
Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence and the treatment period 2 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
157  (48) 190  (64)
4.Secondary Outcome
Title Time to Peak Exposure (Tmax)
Hide Description Time to peak exposure over 24 hours (24h) at steady state on day 5.
Time Frame 24 hours (day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Hide Arm/Group Description:
Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence and the treatment period 2 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence.
Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence and the treatment period 2 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence.
Overall Number of Participants Analyzed 26 26
Median (Full Range)
Unit of Measure: hours
4
(3 to 9)
1
(1 to 3)
5.Secondary Outcome
Title Percentage Peak-trough Fluctuation (% PTF)
Hide Description

Percentage peak-trough fluctuation over 24 hours (24h) at steady state on day 5.

Percent peak-to-trough fluctuation is calculated as (Cmax - Cmin)/Cav*100, where Cmax is the maximum observed concentration, Cmin is the minimum observed concentration and Cav is the average concentration over 24 hours (where Cav = AUCss/24).

Time Frame 24 hours (day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Hide Arm/Group Description:
Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence and the treatment period 2 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence.
Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence and the treatment period 2 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: percentage of fluctuation
76.9  (20.0) 91.1  (20.0)
6.Secondary Outcome
Title Percentage Swing
Hide Description

Percentage swing is a pharmacokinetic parameter recommended by the FDA for submission and is calculated as follows:((Cmax,ss - Cmin,ss)/Cmin,ss)*100. It was calculated over 24 hours on day 5.

Where:

Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state.

Time Frame 24 hours (day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Hide Arm/Group Description:
Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence and the treatment period 2 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence.
Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence and the treatment period 2 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: percentage of fluctuation
131  (52) 133  (40)
7.Secondary Outcome
Title Half-value Duration (HVD)
Hide Description Time over which plasma concentrations were above one half Cmax on day 5. 24h = 24 hours.
Time Frame 24 hours (day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Hide Arm/Group Description:
Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence and the treatment period 2 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence.
Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence and the treatment period 2 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: hours
20.7  (2.56) 22.0  (2.24)
8.Secondary Outcome
Title Plateau Time (T75%Cmax)
Hide Description Time over which plasma concentrations were above 75% Cmax on day 5. 24h = 24 hours.
Time Frame 24 hours (day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Hide Arm/Group Description:
Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence and the treatment period 2 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence.
Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence and the treatment period 2 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: hours
11.5  (4.5) 9.2  (3.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Hide Arm/Group Description Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence and the treatment period 2 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence. Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the "Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First" treatment sequence and the treatment period 2 data from subjects in the "Test (Tramadol HCl OAD 200 mg) First" treatment sequence.
All-Cause Mortality
Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol HCl OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (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 OAD 200 mg Tramadol IR (Ultram®) 50 mg 6-hourly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/26 (46.15%)      10/26 (38.46%)    
Blood and lymphatic system disorders     
ALT elevated/raised  1  0/26 (0.00%)  0 2/26 (7.69%)  2
Gastrointestinal disorders     
Constipation * 1  4/26 (15.38%)  4 3/26 (11.54%)  3
Nausea * 1  3/26 (11.54%)  3 1/26 (3.85%)  1
Vomiting * 1  3/26 (11.54%)  4 1/26 (3.85%)  2
General disorders     
Dry mouth * 1  2/26 (7.69%)  2 0/26 (0.00%)  0
Headache * 1  5/26 (19.23%)  5 3/26 (11.54%)  4
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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: 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