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| ID | Type | Description | Link |
|---|---|---|---|
| TAN-P8-681 |
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| Name | Class |
|---|---|
| Algorithme Pharma Inc | INDUSTRY |
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The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations
The bioavailability of once-daily trazodone extended-release 300 mg caplets (test product) and trazodone immediate-release 100 mg tablets administered q8h (reference product) will be compared in healthy adult volunteers in a randomized, crossover fashion. Morning doses will be administered after an overnight fast. Blood samples will be collected predose and at pre-defined times over 72 hours following the morning dose. Pharmacokinetic parameters will be analyzed using ANOVA. Comparative bioavailability will be assessed on the basis of the ratio of least-squares means and/or 90% confidence interval criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trazodone Contramid OAD | Experimental |
| |
| Desyrel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazodone HCl | Drug | 100 mg immediate-release tablet, dosing q8h |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence Based on Cmax | Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL) | 72 hours post-dose |
| Bioequivalence Based on AUCT | AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration | 72 hours post-dose |
| Bioequivalence Based on AUC∞ | AUC∞ = Area under the concentration-time curve extrapolated to infinity | 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Measured Plasma Concentration (Tmax) | 72 hours post-dose | |
| Apparent Terminal Elimination Half-Life [T½el] | The elimination half-life (T½el) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sicard, MD | Algorithme Pharma Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algorithme Pharma Inc. | Laval | Quebec | H7V 4B3 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
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| Washout Period of 7 Days |
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| Second Intervention Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive Test first and Reference first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bioequivalence Based on Cmax | Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL) | The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods. | Posted | Mean | Standard Deviation | ng/mL | 72 hours post-dose |
|
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trazodone Contramid® OAD | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Labopharm Inc. | 1 450 686 1017 |
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| ID | Term |
|---|---|
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
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| Trazodone HCl |
| Drug |
300 mg extended-release caplet, single dose |
|
|
| 72 hours post-dose |
| Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24] | 24 hours |
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| NOT COMPLETED |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Desyrel® |
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 |
|
|
|
| Primary | Bioequivalence Based on AUCT | AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration | The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods. | Posted | Mean | Standard Deviation | ng*h/mL | 72 hours post-dose |
|
|
|
|
| Primary | Bioequivalence Based on AUC∞ | AUC∞ = Area under the concentration-time curve extrapolated to infinity | The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods. | Posted | Mean | Standard Deviation | ng*h/mL | 72 hours post-dose |
|
|
|
|
| Secondary | Time of Maximum Measured Plasma Concentration (Tmax) | The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods. | Posted | Median | Full Range | hours | 72 hours post-dose |
|
|
|
| Secondary | Apparent Terminal Elimination Half-Life [T½el] | The elimination half-life (T½el) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours. | The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods. | Posted | Mean | Standard Deviation | Hours | 72 hours post-dose |
|
|
|
| Secondary | Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24] | The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods. | Posted | Mean | Standard Deviation | ng*h/mL | 24 hours |
|
|
|
| 0 |
| 23 |
| 20 |
| 23 |
| EG001 | Desyrel® | 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 | 0 | 22 | 21 | 22 |
| Dry eyes | Eye disorders | MedDRA | Non-systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
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| Feeling cold | General disorders | MedDRA | Non-systematic Assessment |
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| Hot flush | General disorders | MedDRA | Non-systematic Assessment |
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| Vessel puncture site reaction | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA | Non-systematic Assessment |
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| Blood pressure systolic decreased | Investigations | MedDRA | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
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| Nitrite urine present | Investigations | MedDRA | Non-systematic Assessment |
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| Binocular eye movement disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
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.
| D011725 |
| Pyridines |