Trial Outcomes & Findings for A Dose Linearity Study of the Labopharm Formulation of Tramadol HCl/Contramid®, 100 mg, 200 mg and 300 mg After A Single Oral Administration In Fasting Condition, In Healthy Human Volunteers (NCT NCT00834808)

NCT ID: NCT00834808

Last Updated: 2012-04-27

Results Overview

Area under the plasma concentration versus time curve to the last measurable concentration. h = hours

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 27 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2012-04-27

Participant Flow

Participant milestones

Measure	1: Tramadol HCl 100mg * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	2: Tramadol HCl 200mg * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	3: Tramadol HCl 300mg * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.
Treatment Period 1 (Day 1) STARTED	9	9	9
Treatment Period 1 (Day 1) COMPLETED	9	9	9
Treatment Period 1 (Day 1) NOT COMPLETED	0	0	0
Treatment Period 2 (Day 8) STARTED	9	9	9
Treatment Period 2 (Day 8) COMPLETED	9	9	9
Treatment Period 2 (Day 8) NOT COMPLETED	0	0	0
Treatment Period 3 (Day 15) STARTED	9	9	9
Treatment Period 3 (Day 15) COMPLETED	9	9	9
Treatment Period 3 (Day 15) NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Dose Linearity Study of the Labopharm Formulation of Tramadol HCl/Contramid®, 100 mg, 200 mg and 300 mg After A Single Oral Administration In Fasting Condition, In Healthy Human Volunteers

Baseline characteristics by cohort

Measure	1: Tramadol HCl 100mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	2: Tramadol HCl 200mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	3: Tramadol HCl 300mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0.0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	27.0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0.0 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0.0 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	27.0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours

Area under the plasma concentration versus time curve to the last measurable concentration.

h = hours

Outcome measures

Measure	1: Tramadol HCl 100mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	2: Tramadol HCl 200mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	3: Tramadol HCl 300mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.
AUC(0-t)	2064 ng.h/mL Standard Deviation 707	4332 ng.h/mL Standard Deviation 1149	6568 ng.h/mL Standard Deviation 2050

PRIMARY outcome

Timeframe: 48 hours

Area under the plasma concentration versus time curve extrapolated to infinity. h = hours

Outcome measures

Measure	1: Tramadol HCl 100mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	2: Tramadol HCl 200mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	3: Tramadol HCl 300mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.
AUC(0-inf)	2108 ng.h/mL Standard Deviation 731	4416 ng.h/mL Standard Deviation 1192	6741 ng.h/mL Standard Deviation 2156

PRIMARY outcome

Timeframe: 48 hours

Maximum plasma concentration.

Outcome measures

Measure	1: Tramadol HCl 100mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	2: Tramadol HCl 200mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	3: Tramadol HCl 300mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.
Cmax	91 ng/mL Standard Deviation 27	197 ng/mL Standard Deviation 58	290 ng/mL Standard Deviation 147

SECONDARY outcome

Timeframe: 48 hours

Time to maximum plasma concentration

Outcome measures

Measure	1: Tramadol HCl 100mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	2: Tramadol HCl 200mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	3: Tramadol HCl 300mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.
Tmax	9 hours Interval 3.0 to 16.0	5.5 hours Interval 3.0 to 16.0	5 hours Interval 3.0 to 24.0

SECONDARY outcome

Timeframe: 48 hours

Apparent terminal elimination half-life

Outcome measures

Measure	1: Tramadol HCl 100mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	2: Tramadol HCl 200mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.	3: Tramadol HCl 300mg n=9 Participants * Single oral administration fasting conditions. * Randomization schedule based on a Latin Square design.
t1/2	6.1 hours Standard Deviation 1.3	6.1 hours Standard Deviation 1.3	6.3 hours Standard Deviation 1.5

Adverse Events

1: Tramadol HCl 100mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2: Tramadol HCl 200mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3: Tramadol HCl 300mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Regulatory Affairs

Labopharm Inc.

Phone: 1 450 686 1017

Results disclosure agreements

• Principal investigator is a sponsor employee The publication of the results obtained will be authorized, after prior agreement between the various recipients \[investigator and sponsor\].
• Publication restrictions are in place

Restriction type: OTHER