Trial Outcomes & Findings for Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions (NCT NCT00834912)
NCT ID: NCT00834912
Last Updated: 2012-04-30
Results Overview
Area under the plasma concentration (AUC) versus time curve to the last measurable concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
48 hours
Results posted on
2012-04-30
Participant Flow
Participant milestones
| Measure |
Confab Fasting / Confab Fed / Trillium Fasting
Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
|
Confab Fasting / Trillium Fasting / Confab Fed
Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
|
Confab Fed / Confab Fasting / Trillium Fasting
Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
|
Confab Fed / Trillium Fasting / Confab Fasting
Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
|
Trillium Fasting / Confab Fasting / Confab Fed
Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
|
Trillium Fasting / Confab Fed / Confab Fasting
Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Treatment Period 1
COMPLETED
|
6
|
5
|
6
|
5
|
6
|
6
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
STARTED
|
6
|
5
|
6
|
5
|
6
|
6
|
|
Treatment Period 2
COMPLETED
|
6
|
5
|
5
|
5
|
5
|
6
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Treatment Period 3
STARTED
|
6
|
5
|
5
|
5
|
5
|
6
|
|
Treatment Period 3
COMPLETED
|
6
|
5
|
5
|
5
|
5
|
6
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Confab Fasting / Confab Fed / Trillium Fasting
Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
|
Confab Fasting / Trillium Fasting / Confab Fed
Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
|
Confab Fed / Confab Fasting / Trillium Fasting
Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
|
Confab Fed / Trillium Fasting / Confab Fasting
Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
|
Trillium Fasting / Confab Fasting / Confab Fed
Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
|
Trillium Fasting / Confab Fed / Confab Fasting
Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions
Baseline characteristics by cohort
| Measure |
Confab Fasting / Confab Fed / Trillium Fasting
n=6 Participants
Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
|
Confab Fasting / Trillium Fasting / Confab Fed
n=6 Participants
Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
|
Confab Fed / Confab Fasting / Trillium Fasting
n=6 Participants
Confab fed / Confab fasting / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
|
Confab Fed / Trillium Fasting / Confab Fasting
n=6 Participants
Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
|
Trillium Fasting / Confab Fasting / Confab Fed
n=6 Participants
Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
|
Trillium Fasting / Confab Fed / Confab Fasting
n=6 Participants
Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
|
Total
n=36 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 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Data from all randomized subjects who completed at least 2 periods of the study are presented.
Area under the plasma concentration (AUC) versus time curve to the last measurable concentration.
Outcome measures
| Measure |
1: Tramadol HCl 300 mg (Confab Laboratories) Fasting
n=34 Participants
Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
|
2: Tramadol HCl 300 mg (Confab Laboratories) Fed
n=33 Participants
Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
|
3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting
n=33 Participants
Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
|
|---|---|---|---|
|
AUC(0-t)
|
9708 ng.h/mL
Standard Deviation 3875
|
9696 ng.h/mL
Standard Deviation 3750
|
9431 ng.h/mL
Standard Deviation 3225
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variables AUC(0-∞) of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.
The area under the plasma concentration (AUC) curve was estimated by extrapolating to infinity AUC0-t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R'2 (coefficient of determination). The units are ng.h/mL. h=hours
Outcome measures
| Measure |
1: Tramadol HCl 300 mg (Confab Laboratories) Fasting
n=33 Participants
Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
|
2: Tramadol HCl 300 mg (Confab Laboratories) Fed
n=33 Participants
Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
|
3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting
n=33 Participants
Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
|
|---|---|---|---|
|
AUC(0-∞)
|
9882 ng.h/mL
Standard Deviation 3933
|
9898 ng.h/mL
Standard Deviation 3970
|
10095 ng.h/mL
Standard Deviation 4070
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Data from all randomized subjects who completed at least 2 periods of the study are presented.
Maximum plasma concentration (Cmax)
Outcome measures
| Measure |
1: Tramadol HCl 300 mg (Confab Laboratories) Fasting
n=34 Participants
Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
|
2: Tramadol HCl 300 mg (Confab Laboratories) Fed
n=33 Participants
Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
|
3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting
n=33 Participants
Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
|
|---|---|---|---|
|
Cmax
|
433 ng/mL
Standard Deviation 206
|
728 ng/mL
Standard Deviation 317
|
402 ng/mL
Standard Deviation 201
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data from all randomized subjects who completed at least 2 periods of the study are presented.
Time to maximum plasma concentration (Tmax)
Outcome measures
| Measure |
1: Tramadol HCl 300 mg (Confab Laboratories) Fasting
n=34 Participants
Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
|
2: Tramadol HCl 300 mg (Confab Laboratories) Fed
n=33 Participants
Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
|
3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting
n=33 Participants
Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
|
|---|---|---|---|
|
Tmax
|
7 hours
Interval 2.0 to 24.0
|
8 hours
Interval 3.0 to 20.0
|
12 hours
Interval 3.0 to 24.0
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variable T1/2 of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.
Apparent terminal elimination half-life (t1/2)
Outcome measures
| Measure |
1: Tramadol HCl 300 mg (Confab Laboratories) Fasting
n=33 Participants
Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
|
2: Tramadol HCl 300 mg (Confab Laboratories) Fed
n=33 Participants
Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
|
3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting
n=33 Participants
Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
|
|---|---|---|---|
|
t1/2
|
7.70 hours
Standard Deviation 1.97
|
6.61 hours
Standard Deviation 1.66
|
8.32 hours
Standard Deviation 2.84
|
Adverse Events
1: Tramadol HCl 300 mg (Confab Laboratories) Fasting
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
2: Tramadol HCl 300 mg (Confab Laboratories) Fed
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1: Tramadol HCl 300 mg (Confab Laboratories) Fasting
n=36 participants at risk
Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
|
2: Tramadol HCl 300 mg (Confab Laboratories) Fed
n=36 participants at risk
Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
|
3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting
n=36 participants at risk
Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
|
|---|---|---|---|
|
Nervous system disorders
Difficulty to concentrate
|
0.00%
0/36
|
5.6%
2/36 • Number of events 2
|
0.00%
0/36
|
|
Renal and urinary disorders
Difficulty voiding bladder
|
5.6%
2/36 • Number of events 2
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
33.3%
12/36 • Number of events 12
|
30.6%
11/36 • Number of events 13
|
19.4%
7/36 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/36
|
5.6%
2/36 • Number of events 2
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
|
Psychiatric disorders
Feels euphoric
|
11.1%
4/36 • Number of events 4
|
11.1%
4/36 • Number of events 4
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
Feels sleepy
|
19.4%
7/36 • Number of events 7
|
19.4%
7/36 • Number of events 7
|
16.7%
6/36 • Number of events 6
|
|
General disorders
Headache
|
8.3%
3/36 • Number of events 3
|
19.4%
7/36 • Number of events 7
|
8.3%
3/36 • Number of events 3
|
|
Cardiac disorders
Hot flashes
|
8.3%
3/36 • Number of events 3
|
16.7%
6/36 • Number of events 6
|
13.9%
5/36 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Itching
|
8.3%
3/36 • Number of events 3
|
11.1%
4/36 • Number of events 4
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
27.8%
10/36 • Number of events 11
|
36.1%
13/36 • Number of events 14
|
25.0%
9/36 • Number of events 9
|
|
Gastrointestinal disorders
Stomach ache
|
0.00%
0/36
|
5.6%
2/36 • Number of events 2
|
0.00%
0/36
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
8/36 • Number of events 8
|
27.8%
10/36 • Number of events 10
|
22.2%
8/36 • Number of events 8
|
|
General disorders
Weakness
|
5.6%
2/36 • Number of events 2
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
Additional Information
Director of Regulatory Affairs
Labopharm Inc.
Phone: 1 450 686 1017
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the study results may only be allowed with written permission from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER