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

Not Applicable

Completed

• Conditions: Drug Mechanism; Healthy
• Interventions: Drug: Paracetamol; Diagnostic Test: Paracetamol concentration measurements and lipidomic assessment

• Registration Number: NCT04690673
• Lead Sponsor: Johanna Kujala

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-31
• Study Start: 2021-01-15
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-15
• Results First Submitted: 2023-08-21
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Results First Posted: 2025-02-03
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Paracetamol concentration measurements and lipidomic assessment	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.
Study group	Paracetamol	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.

Primary Outcome Measures

Name	Time	Method
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 day	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol in Capillary With Venous Plasma (Control), Both Measured by Mass-spectrometry.	12 hours	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).

Trial Locations

Locations (1)

Helsinki university hospital; 🇫🇮 Helsinki, Finland