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

Johanna Kujala

Status: Completed

Conditions: Healthy; Drug Mechanism

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04690673

FEPODPara2020-1

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Study group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Paracetamol concentration measurements and lipidomic assessment

Drug: Paracetamol