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Completed

NCT Number: NCT04690673

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

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.

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Key information

Conditions

Drug Mechanism Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki university hospital

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

1 g oral paractamol

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.

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.

    Time frame: 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 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.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Johanna Kujala

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 31, 2020
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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