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

NCT04690673 | Completed Results

• 1 other identifier: FEPODPara2020-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Mechanism; Healthy

Keywords

electrochemical; Paracetamol; Lipidomics; Endocannabinoid system

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 day

Secondary Outcomes (1)

• 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

Study Arms (1)

Study group

EXPERIMENTAL

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.

Drug: Paracetamol; Diagnostic Test: Paracetamol concentration measurements and lipidomic assessment

Interventions

Paracetamol DRUG

1 g oral paractamol

Study group

Paracetamol concentration measurements and lipidomic assessment DIAGNOSTIC_TEST

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.

Study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, no medication of any kind.
• Age 18-45
• BMI 18.5 - 30
• Informed consent

You may not qualify if:

• Pregnancy, lactation.
• prisoner
• smoking
• less than 3 months from prior blood donation or clinical pharmacological study

Sponsors & Collaborators

• Johanna Kujala: lead

Study Sites (1)

Helsinki university hospital

Helsinki, Finland

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr Johanna Kujala
• Organization: Helsinki and Uusimaa Hospital District, Pain clinic

johanna.kujala@helsinki.fi

+358400780411

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Healthy volunteers

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 31, 2020
• Study Start: January 15, 2021
• Primary Completion: March 31, 2021
• Study Completion: April 15, 2021
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)