Measurement of paracetamol concentration with a novel electrochemical technique from fingerprick-, saline - and urine samples.

Detection of paracetamol concentration in blood-, saline- and urine samples with an electrochemical indicator in healthy volunteers - a validation study for a novel technique.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002908-39-FI

Enrollment

Registered

2020-10-22

Start date

2020-10-30

Completion date

Unknown

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This is a laboratory equipment validation study. All subjects are healthy volunteered individuals.

Interventions

Trade Name: Panadol Product Name: Panadol Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Informed consent. Healthy, normal weight, age 18-45. Must pass medical examination prior to inclusion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not considered healthy. Alcohol, tobacco, or illegal substance use. Regular medication incl contraceptives Pregnancy, planned pregnancy or lactation Participation in another clinical trial within 3 monts Blood donation within 3 monts. BMI 30

Design outcomes

Primary

Measure	Time frame
Main Objective: 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, ages 18-45. They will get 1 g oral paracetamol. Paracetamol concentration will be detected from abovementioned samples at timely intervals for 12 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis. ;Secondary Objective: Despite of vast 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 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. ;Primary end point(s): Validation of the novel laboratory analysis method.;Timepoint(s) of evaluation of this end point: 12 hours post adminitration of paracetamol	—

Measure

Time frame

Main Objective: 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, ages 18-45. They will get 1 g oral paracetamol. Paracetamol concentration will be detected from abovementioned samples at timely intervals for 12 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis. ;Secondary Objective: Despite of vast 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 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. ;Primary end point(s): Validation of the novel laboratory analysis method.;Timepoint(s) of evaluation of this end point: 12 hours post adminitration of paracetamol

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in serum lipidomics after administration of paracetamol.;Timepoint(s) of evaluation of this end point: 24 hours post administration of paracetamol	—

Countries

Finland

Contacts

Public ContactJohanna Kujala

Helsinki University Hospital

johanna.kujala@helsinki.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026