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| Name | Class |
|---|---|
| International Pharmaceutical Research Center | OTHER |
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This study aims to demonstrate the bioequivalence between the formulation of 5 mg/mL Tramadol Hydrochloride Oral Solution (08P1902F0) Relative to the reference product Contramal® (100 mg/mL Oral Solution).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol hydrochloride 5mg/mL oral solution (IMP 08P1902F0) | Experimental |
| |
| Tramadol hydrochloride 100mg/mL oral solution (Contramal(r)) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol Hydrochloride 5 MG/ML Oral Solution | Drug | 50mg (10mL) single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Tramadol Hydrochloride for the Test and the Reference Products | The maximum concentration in plasma among observed concentrations at pre-specified time points | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
| AUC0-t of Tramadol Hydrochloride for the Test and the Reference Products | The area under the plasma concentration versus time curve from time 0 to the last measured concentration | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity of Tramadol Hydrochloride for the Test and the Reference Products | The area under the plasma concentration versus time curve from time 0 to to infinite time | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
| Kel of Tramadol Hydrochloride for the Test and the Reference Products |
| Measure | Description | Time Frame |
|---|---|---|
| Palatability Questionnaire | 5 point scale: from 1 : very bad after taste to 5 : very good after taste | 0 and 2 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Majdi Abu Awida, M.D | IPRC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IPRC reserach site facility | Amman | 11196 | Jordan |
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cross-over study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tramadol HCl 5mg/mL Oral Solution IMP08P1902F0 Then Tramadol HCl 100mg/mL Oral Solution Contramal(r) | Participants first received Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose (IMP 08P1902F0) manufactured by Unither Liquid Manufacturing in a fasting state. After a washout period of 1 week, they received Tramadol HCl 100mg/mL oral solution Contramal(r) manufactured by Grunenthal GmbH in a fasting state |
| FG001 | Tramadol HCl 100mg/mL Oral Solution Contramal(r) Then Tramadol HCl 5mg/mL Oral Solution IMP08P1902F0 | Participants first received Tramadol HCl 100mg/mL oral solution Contramal(r) manufactured by Grunenthal GmbH in a fasting state. After a washout period of 1 week, they received Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose (IMP 08P1902F0) manufactured by Unither Liquid Manufacturing in a fasting state. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period I |
| |||||||||||||
| Period II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tramadol HCl 5mg/mL Oral Solution IMP08P1902F0 Then Tramadol HCl 100mg/mL Oral Solution Contramal(r) | Participants first received Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose (IMP 08P1902F0) manufactured by Unither Liquid Manufacturing in a fasting state. After a washout period of 1 week, they received Tramadol HCl 100mg/mL oral solution Contramal(r) manufactured by Grunenthal GmbH in a fasting state |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cmax of Tramadol Hydrochloride for the Test and the Reference Products | The maximum concentration in plasma among observed concentrations at pre-specified time points | Posted | Mean | Standard Deviation | ng/mL | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
|
Before dosing and 24 hours after each intervention administration, up to 2 days total
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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 Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0) | Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Non-clinical & clinical Project Manager | Unither-Pharmaceuticals | 33 (0)1 44 63 51 78 | clinicaltrials@unither-pharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2022 | Oct 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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Open-label, randomized, single dose, two-sequence, two-period crossover study
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| Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)) | Drug | 50mg (20 drops) single dose |
|
The elimination rate constant |
| predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
| Tmax of Tramadol Hydrochloride for the Test and the Reference Products | Time of the maximum measured plasma concentration. Determined directly from the plasma concentration-time curve. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value. | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
| T1/2 of Tramadol Hydrochloride for the Test and the Reference Products | Plasma Elimination Half-Life | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
| Number of Treatment-related Adverse Events | Occurence and severity of adverse events (serious and non serious adverse events) | Day 1 to Day 11 (end of study) |
| NOT COMPLETED |
|
| BG001 | Tramadol HCl 100mg/mL Oral Solution Contramal(r) Then Tramadol HCl 5mg/mL Oral Solution IMP08P1902F0 | Participants first received Tramadol HCl 100mg/mL oral solution Contramal(r) manufactured by Grunenthal GmbH in a fasting state. After a washout period of 1 week, they received Tramadol Hydrochloride 5 MG/ML Oral Solution: 50mg (10mL) single dose (IMP 08P1902F0) manufactured by Unither Liquid Manufacturing in a fasting state. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | AUC0-t of Tramadol Hydrochloride for the Test and the Reference Products | The area under the plasma concentration versus time curve from time 0 to the last measured concentration | Posted | Mean | Standard Deviation | ng*h/mL | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
|
|
|
| Secondary | AUC0-infinity of Tramadol Hydrochloride for the Test and the Reference Products | The area under the plasma concentration versus time curve from time 0 to to infinite time | Posted | Mean | Standard Deviation | ng*h/mL | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
|
|
|
| Secondary | Kel of Tramadol Hydrochloride for the Test and the Reference Products | The elimination rate constant | Posted | Mean | Standard Deviation | L/h | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
|
|
|
| Secondary | Tmax of Tramadol Hydrochloride for the Test and the Reference Products | Time of the maximum measured plasma concentration. Determined directly from the plasma concentration-time curve. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value. | Posted | Mean | Full Range | h | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
|
|
|
| Secondary | T1/2 of Tramadol Hydrochloride for the Test and the Reference Products | Plasma Elimination Half-Life | Posted | Mean | Standard Deviation | h | predose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours |
|
|
|
| Secondary | Number of Treatment-related Adverse Events | Occurence and severity of adverse events (serious and non serious adverse events) | Posted | Number | adverse events | Day 1 to Day 11 (end of study) |
|
|
|
| Other Pre-specified | Palatability Questionnaire | 5 point scale: from 1 : very bad after taste to 5 : very good after taste | Posted | Number | percentage of participant | 0 and 2 minutes |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r)) | Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)): 50mg (20 drops) single dose | 0 | 24 | 0 | 24 | 0 | 24 |
The results of this study are Unither-Pharmaceuticals proprietary and cannot be published or presented in any scientific meeting without any agreement from the sponsor.
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D004364 | Pharmaceutical Preparations |
| no taste at 0 min |
|
| good taste at 0 min |
|
| very good taste at 0 min |
|
| Very bad after taste at 2 min |
|
| bad after taste at 2 min |
|
| no after taste at 2 min |
|
| good after taste at 2 min |
|
| very good after taste at 2 min |
|