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The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Tramadol Contramid Once A Day | Experimental |
| |
| 2 Zytram (R) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol Contramid OAD | Drug | 1 Tramadol Contramid OAD 200 mg tablet as a single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t) | Area under the plasma concentration versus time curve to the last measured concentration. h=hour | 48 hours |
| AUC (0-∞) | The area under the plasma concentration 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 | 48 hours |
| Cmax | Maximum plasma concentration | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| t1/2 | Apparent terminal elimination half-life | 48 hours |
| Tmax | Time to maximum plasma concentration | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16894407 | Result | Hernandez-Lopez C, Martinez-Farnos L, Karhu D, Perez-Campos T, Rovira S, Encina G. Comparative bioavailability between two Tramadol once-daily oral formulations. Methods Find Exp Clin Pharmacol. 2006 Jul-Aug;28(6):373-8. doi: 10.1358/mf.2006.28.6.1007674. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tramadol Contramid Once A Day | Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period. OAD: Once-A-Day |
| FG001 | Zytram (R) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase I |
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| Zytram | Drug | 1 Zytram 200 mg tablet as a single dose |
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Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period. OAD: Once-A-Day |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Phase II |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tramadol Contramid Once A Day | Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period. OAD: Once-A-Day |
| BG001 | Zytram (R) | Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period. OAD: Once-A-Day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | AUC(0-t) | Area under the plasma concentration versus time curve to the last measured concentration. h=hour | Posted | Mean | Standard Deviation | ng.h/mL | 48 hours |
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| Primary | AUC (0-∞) | The area under the plasma concentration 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 | Posted | Mean | Standard Deviation | ng.h/mL | 48 hours |
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| Primary | Cmax | Maximum plasma concentration | Posted | Mean | Standard Deviation | ng/mL | 48 hours |
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| Secondary | t1/2 | Apparent terminal elimination half-life | Posted | Mean | Standard Deviation | hours | 48 hours |
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| Secondary | Tmax | Time to maximum plasma concentration | Posted | Median | Full Range | hours | 48 hours |
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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 | Tramadol Contramid Once A Day | Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period. OAD: Once-A-Day | 0 | 26 | 8 | 26 | ||
| EG001 | Zytram (R) | Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period. OAD: Once-A-Day | 0 | 26 | 9 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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The investigator must agree to maintain the confidentiality of the study at all times, and he cannot reveal any information coming from the protocol, the study results or any documentation related to the study, without permission of the sponsor. Any publication of the results, in whole or in part will require the permission of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Labopharm Inc. | 1 450 686 1017 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
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| >=65 years |
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| Male |
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