Trial Outcomes & Findings for A Study to Compare the Relative Bioavailability of Two 200 Mg Tramadol Hydrochloride Tablet Products Under Fasting Conditions (NCT NCT00834366)

NCT ID: NCT00834366

Last Updated: 2012-04-30

Results Overview

Area under plasma concentration versus time curve to the last measurable concentration. Unit is ng.h/mL. h=hours.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 26 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2012-04-30

Participant Flow

Participant milestones

Measure	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.
Treatment Period 1 STARTED	13	13
Treatment Period 1 COMPLETED	12	12
Treatment Period 1 NOT COMPLETED	1	1
Treatment Period 2 STARTED	12	12
Treatment Period 2 COMPLETED	12	12
Treatment Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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.
Treatment Period 1 Adverse Event	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tramadol HCl 200 mg Film-coated Tablets n=13 Participants 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 n=13 Participants Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26.0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11.0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15.0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Area under plasma concentration versus time curve to the last measurable concentration. Unit is ng.h/mL. h=hours.

Outcome measures

Measure	Tramadol HCl 200 mg Film-coated Tablets n=12 Participants 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 n=12 Participants Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
AUC(0-t)	5181 ng.h/mL Standard Deviation 1338	5010 ng.h/mL Standard Deviation 1176

PRIMARY outcome

Timeframe: 48 hours

Area under plasma concentration versus time curve extrapolated to infinity. Unit is ng.h/mL. h=hour.

Outcome measures

Measure	Tramadol HCl 200 mg Film-coated Tablets n=12 Participants 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 n=12 Participants Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
AUC(0-Inf)	5328 ng.h/mL Standard Deviation 1421	5175 ng.h/mL Standard Deviation 1241

PRIMARY outcome

Timeframe: 48 hours

Maximum plasma concentration

Outcome measures

Measure	Tramadol HCl 200 mg Film-coated Tablets n=12 Participants 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 n=12 Participants Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Cmax	218 ng/mL Standard Deviation 49	209 ng/mL Standard Deviation 45

SECONDARY outcome

Timeframe: 48 hours

Time to the maximum concentration

Outcome measures

Measure	Tramadol HCl 200 mg Film-coated Tablets n=12 Participants 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 n=12 Participants Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Tmax	6 hours Interval 3.0 to 12.0	6 hours Interval 3.0 to 10.0

SECONDARY outcome

Timeframe: 48 hours

Apparent terminal elimination half-life

Outcome measures

Measure	Tramadol HCl 200 mg Film-coated Tablets n=12 Participants 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 n=12 Participants Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
t1/2	7.08 hours Standard Deviation 1.45	7.38 hours Standard Deviation 1.76

Adverse Events

Tramadol HCl 200 mg Film-coated Tablets

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Tramadol HCl 200 mg Uncoated Tablets

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tramadol HCl 200 mg Film-coated Tablets n=25 participants at risk 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 n=25 participants at risk Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Nervous system disorders Drowsiness	4.0% 1/25 • Number of events 1	20.0% 5/25 • Number of events 5
Nervous system disorders Dizziness	28.0% 7/25 • Number of events 9	24.0% 6/25 • Number of events 6
Gastrointestinal disorders Nausea	16.0% 4/25 • Number of events 4	4.0% 1/25 • Number of events 2

Additional Information

Director of Regulatory Affairs

Labopharm Inc.

Phone: 1 450 686 1017

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER