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

NCT ID: NCT04690673

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-04-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study group

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.

Group Type: EXPERIMENTAL

Paracetamol

Intervention Type: DRUG

1 g oral paractamol

Paracetamol concentration measurements and lipidomic assessment

Intervention Type: 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.

Interventions

Paracetamol

1 g oral paractamol

Intervention Type: DRUG

Paracetamol concentration measurements and lipidomic assessment

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johanna Kujala

OTHER

Sponsor Role: lead

Responsible Party

Johanna Kujala

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Helsinki university hospital

Helsinki, , Finland

Countries

Finland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FEPODPara2020-1

Identifier Type: -

Identifier Source: org_study_id