Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique
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|ClinicalTrials.gov Identifier: NCT04690673|
Recruitment Status : Completed
First Posted : December 31, 2020
Last Update Posted : December 8, 2021
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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.
|Condition or disease||Intervention/treatment||Phase|
|Drug Mechanism Healthy||Drug: Paracetamol Diagnostic Test: Paracetamol concentration measurements and lipidomic assessment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Healthy volunteers|
|Masking:||None (Open Label)|
|Official Title:||Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples With an Electrochemical Indicator in Healthy Volunteers - a Validation Study for a Novel Technique|
|Actual Study Start Date :||January 15, 2021|
|Actual Primary Completion Date :||March 31, 2021|
|Actual Study Completion Date :||April 15, 2021|
Experimental: 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.
1 g oral paractamol
Diagnostic Test: 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.
- Paracetamol concentration will be measured with the novel electrochemical method and mass-spectrometry. [ Time Frame: 1 day ]Paracetamol concentration will be measured with the novel electrochemical method and gold standard mass-spectrometry. Measurements are made from fingerprick-, venous blood-, saliva-, and urine samples. Measured concentrations are compared between matrixes and between laboratory analysis techniques.
- Changes in serum lipidomics after administration of paracetamol [ Time Frame: 1 day ]Mechanism of action of paracetamol is not exactly known. We will assess changes in serum lipidomic measurement after paracetamol administration in healthy individuals
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Healthy, no medication of any kind.
- Age 18-45
- BMI 18.5 - 30
- Informed consent
- Pregnancy, lactation.
- less than 3 months from prior blood donation or clinical pharmacological study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690673
|Helsinki university hospital|
|Responsible Party:||Johanna Kujala, Sponsor-Investigator, Helsinki University Central Hospital|
|Other Study ID Numbers:||
|First Posted:||December 31, 2020 Key Record Dates|
|Last Update Posted:||December 8, 2021|
|Last Verified:||November 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs