Trial Outcomes & Findings for Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers (NCT NCT00839072)
NCT ID: NCT00839072
Last Updated: 2012-04-27
Results Overview
Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
72 hours post-dose
Results posted on
2012-04-27
Participant Flow
Participant milestones
| Measure |
Test (Trazodone Contramid® OAD) First
1 \* 300 mg Trazodone Contramid® OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Trazodone IR (Desyrel®) 100 mg tablet 8-hourly reference product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.
IR = Immediate Release.
|
Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First
1 \* 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone Contramid® OAD (Once-A-Day) 300 mg 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.
|
|---|---|---|
|
First Intervention Period
STARTED
|
12
|
12
|
|
First Intervention Period
COMPLETED
|
10
|
11
|
|
First Intervention Period
NOT COMPLETED
|
2
|
1
|
|
Washout Period of 7 Days
STARTED
|
10
|
11
|
|
Washout Period of 7 Days
COMPLETED
|
10
|
11
|
|
Washout Period of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Period
STARTED
|
10
|
11
|
|
Second Intervention Period
COMPLETED
|
9
|
11
|
|
Second Intervention Period
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Test (Trazodone Contramid® OAD) First
1 \* 300 mg Trazodone Contramid® OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Trazodone IR (Desyrel®) 100 mg tablet 8-hourly reference product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.
IR = Immediate Release.
|
Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First
1 \* 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone Contramid® OAD (Once-A-Day) 300 mg 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.
|
|---|---|---|
|
First Intervention Period
Withdrawal by Subject
|
1
|
0
|
|
First Intervention Period
Adverse Event
|
1
|
1
|
|
Second Intervention Period
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=24 Participants
Includes groups randomized to receive Test first and Reference first.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age Continuous
|
35 years
STANDARD_DEVIATION 6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
24 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 72 hours post-dosePopulation: The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.
Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)
Outcome measures
| Measure |
Trazodone Contramid® OAD
n=20 Participants
Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
Desyrel®
n=20 Participants
Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
|---|---|---|
|
Bioequivalence Based on Cmax
|
1060.8 ng/mL
Standard Deviation 366.6
|
1743.3 ng/mL
Standard Deviation 470.1
|
PRIMARY outcome
Timeframe: 72 hours post-dosePopulation: The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.
AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration
Outcome measures
| Measure |
Trazodone Contramid® OAD
n=20 Participants
Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
Desyrel®
n=20 Participants
Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
|---|---|---|
|
Bioequivalence Based on AUCT
|
29180.6 ng*h/mL
Standard Deviation 10557.1
|
36002.4 ng*h/mL
Standard Deviation 9636.4
|
PRIMARY outcome
Timeframe: 72 hours post-dosePopulation: The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.
AUC∞ = Area under the concentration-time curve extrapolated to infinity
Outcome measures
| Measure |
Trazodone Contramid® OAD
n=20 Participants
Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
Desyrel®
n=20 Participants
Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
|---|---|---|
|
Bioequivalence Based on AUC∞
|
30913.7 ng*h/mL
Standard Deviation 11904.8
|
37273.4 ng*h/mL
Standard Deviation 10738.5
|
SECONDARY outcome
Timeframe: 72 hours post-dosePopulation: The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.
Outcome measures
| Measure |
Trazodone Contramid® OAD
n=20 Participants
Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
Desyrel®
n=20 Participants
Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
|---|---|---|
|
Time of Maximum Measured Plasma Concentration (Tmax)
|
6.00 hours
Interval 1.05 to 24.0
|
9.50 hours
Interval 0.33 to 21.0
|
SECONDARY outcome
Timeframe: 72 hours post-dosePopulation: The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.
The elimination half-life (T½el) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.
Outcome measures
| Measure |
Trazodone Contramid® OAD
n=20 Participants
Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
Desyrel®
n=20 Participants
Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
|---|---|---|
|
Apparent Terminal Elimination Half-Life [T½el]
|
14.37 Hours
Standard Deviation 4.31
|
12.16 Hours
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.
Outcome measures
| Measure |
Trazodone Contramid® OAD
n=20 Participants
Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
Desyrel®
n=20 Participants
Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
|---|---|---|
|
Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24]
|
16885.8 ng*h/mL
Standard Deviation 5453.0
|
22512.8 ng*h/mL
Standard Deviation 5045.2
|
Adverse Events
Trazodone Contramid® OAD
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Desyrel®
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trazodone Contramid® OAD
n=23 participants at risk
Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
Desyrel®
n=22 participants at risk
Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/23
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
9.1%
2/22 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Eye disorders
Dry eyes
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
9.1%
2/22 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/23
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
9.1%
2/22 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
0.00%
0/22
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
2/23 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
13.6%
3/22 • Number of events 3
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
9.1%
2/22 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
0.00%
0/22
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
27.3%
6/22 • Number of events 9
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
0.00%
0/22
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
General disorders
Chest pain
|
0.00%
0/23
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
General disorders
Fatigue
|
26.1%
6/23 • Number of events 6
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
18.2%
4/22 • Number of events 5
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
General disorders
Feeling cold
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
0.00%
0/22
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
General disorders
Hot flush
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
0.00%
0/22
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Injury, poisoning and procedural complications
Vessel puncture site reaction
|
0.00%
0/23
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
9.1%
2/22 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Investigations
Blood potassium increased
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Investigations
Blood pressure systolic decreased
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Investigations
Haemoglobin decreased
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Investigations
Nitrite urine present
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Nervous system disorders
Binocular eye movement disorder
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
0.00%
0/22
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Nervous system disorders
Coordination abnormal
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
0.00%
0/22
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Nervous system disorders
Disturbance in attention
|
4.3%
1/23 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
0.00%
0/22
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Nervous system disorders
Dizziness
|
8.7%
2/23 • Number of events 2
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
40.9%
9/22 • Number of events 18
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Nervous system disorders
Headache
|
21.7%
5/23 • Number of events 6
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
13.6%
3/22 • Number of events 4
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/23
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Nervous system disorders
Insomnia
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Nervous system disorders
Somnolence
|
73.9%
17/23 • Number of events 18
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
90.9%
20/22 • Number of events 39
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/23
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
0.00%
0/22
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.3%
1/23 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/23
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
4.5%
1/22 • Number of events 1
A total of 23 subjects were exposed to Trazodone Contramid® OAD during the study (12 during first intervention period and 11 during second intervention period). A total of 22 subjects were exposed to Trazodone IR (Apotex Corp.) during the study (12 during first intervention period and 10 during second intervention period).
|
Additional Information
Director of Regulatory Affairs
Labopharm Inc.
Phone: 1 450 686 1017
Results disclosure agreements
- Principal investigator is a sponsor employee Approval from the sponsor will be required prior to publication of the results of this study and a draft manuscript will be submitted to the sponsor for scrutiny and comment. The choice of scientific journal will be mutually agreed on by the investigator and the sponsor.
- Publication restrictions are in place
Restriction type: OTHER