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The main objective is to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples. We will recruit 12 healthy volunteers aged 18-45. They will get 1 g oral paracetamol. Paracetamol concentration will be detected from abovementioned samples at timely intervals for 24 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis.
Despite of extensive use, the mechanism of action of parasetamol is not completely understood. The central serotonergic system may play a role. Endocannabinoid system is a group of lipid mediators, that possibly is involved in mediating paracetamol effect to the serotonergic system. Serum lipidomic assessment can be used to study endocannabinoid metabolics. In this study we will try to assess changes in endocannabinoid system by looking into serum lipidomics in order to understand the mechanism of action of paracetamol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | All healthy volunteers are in this group. They receive 1g paracetamol orally. Saline-, urine-, venous blood and fingerprick samples will be collected at timely intervals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | 1 g oral paractamol |
| |
| Paracetamol concentration measurements and lipidomic assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol Measured by the Novel Electrochemical Method With Mass-spectrometry in Capillary Whole Blood Samples. | Geometric mean values of the highest paracetamol concentrations (Cmax) and area under the curve (AUC) measured with the novel electrochemical method were compared with the 'gold standard' mass-spectrometry (control) from capillary whole blood samples. The data are presented as the ratio of geometric means to control, geometric coefficients of variation (as percentage) as a measure of dispersion. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol in Capillary With Venous Plasma (Control), Both Measured by Mass-spectrometry. | Geometric mean values of the highest paracetamol concentrations (Cmax) and area under the curve -calculations (AUC0-last) measured by mass-spectrometry were compared between capillary and plasma (control) to analyse paracetamol pharmacokinetics. The data are presented as ratio-to-control with geometric coefficients of variation (as percentage). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki university hospital | Helsinki | Finland |
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No medications or nutritional supplements were allowed prior to the study day.
Recruitment was announced on Helsinki University student's website in January 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | All healthy volunteers are in this group. They receive 1g paracetamol orally. Saline-, urine-, venous blood and fingerprick samples will be collected at timely intervals. Paracetamol: 1 g oral paractamol Paracetamol concentration measurements and lipidomic assessment: Paracetamol concentration is measured from saline-, urine-, venous blood- and fingerprick- samples at timely intervals. Also serum lipidomic assessment is performed from venous blood samples. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | All healthy volunteers are in this group. They receive 1g paracetamol orally. Saline-, urine-, venous blood and fingerprick samples will be collected at timely intervals. Paracetamol: 1 g oral paractamol Paracetamol concentration measurements and lipidomic assessment: Paracetamol concentration is measured from saline-, urine-, venous blood- and fingerprick- samples at timely intervals. Also serum lipidomic assessment is performed from venous blood samples. |
| 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 |
| 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 | Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol Measured by the Novel Electrochemical Method With Mass-spectrometry in Capillary Whole Blood Samples. | Geometric mean values of the highest paracetamol concentrations (Cmax) and area under the curve (AUC) measured with the novel electrochemical method were compared with the 'gold standard' mass-spectrometry (control) from capillary whole blood samples. The data are presented as the ratio of geometric means to control, geometric coefficients of variation (as percentage) as a measure of dispersion. | All healthy volunteers in this group. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio-to-control | 1 day |
|
24 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 | Study Group | All healthy volunteers are in this group. They receive 1g paracetamol orally. Saline-, urine-, venous blood and fingerprick samples will be collected at timely intervals. Paracetamol: 1 g oral paractamol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Johanna Kujala | Helsinki and Uusimaa Hospital District, Pain clinic | +358400780411 | johanna.kujala@helsinki.fi |
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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 | Sep 21, 2020 | Mar 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Healthy volunteers
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| Diagnostic Test |
Paracetamol concentration is measured from saline-, urine-, venous blood- and fingerprick- samples at timely intervals. Also serum lipidomic assessment is performed from venous blood samples. |
|
| 12 hours |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| OG001 | AUC 0-last | Comparison of the geometric means of the area- under-the-curve (AUC) from timepoints 0-last measured with the electrochemical method and the mass-spectrometry (control). Data are presented as ratio-to-control. |
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| Secondary | Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol in Capillary With Venous Plasma (Control), Both Measured by Mass-spectrometry. | Geometric mean values of the highest paracetamol concentrations (Cmax) and area under the curve -calculations (AUC0-last) measured by mass-spectrometry were compared between capillary and plasma (control) to analyse paracetamol pharmacokinetics. The data are presented as ratio-to-control with geometric coefficients of variation (as percentage). | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio-to-control | 12 hours |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| Aniline Compounds |
| D000588 | Amines |