N/A N=12 Diagnostic

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

Drug Mechanism · Healthy

Bottom Line

View on ClinicalTrials.gov: NCT04690673 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: 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. — 1.03; 1.17 ratio-to-control — p=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Paracetamol (Drug); Paracetamol concentration measurements and lipidomic assessment (Diagnostic_test)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Johanna Kujala
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
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.	1.03; 1.17	0.05
SECONDARY Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol in Capillary With Venous Plasma (Control), Both Measured by Mass-spectrometry.	1.50; 1.08	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04690673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.