Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690673
• Other study ID #: FEPODPara2020-1
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: April 15, 2021

Study information

• Verified date: November 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 15, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy, no medication of any kind.

• Age 18-45

• BMI 18.5 - 30

• Informed consent

Exclusion Criteria:

• Pregnancy, lactation.

• prisoner

• smoking

• less than 3 months from prior blood donation or clinical pharmacological study

Related Conditions & MeSH terms

• Drug Mechanism
• Healthy

Intervention

Drug:
• Paracetamol
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.

Locations

Country	Name	City	State
Finland	Helsinki university hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Johanna Kujala

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paracetamol concentration will be measured with the novel electrochemical method and mass-spectrometry.	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.	1 day
Secondary	Changes in serum lipidomics after administration of paracetamol	Mechanism of action of paracetamol is not exactly known. We will assess changes in serum lipidomic measurement after paracetamol administration in healthy individuals	1 day