Trial Outcomes & Findings for Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique (NCT NCT04690673)

Last Updated: 2025-02-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

1 day

Results posted on

2025-02-03

Participant Flow

Recruitment was announced on Helsinki University student's website in January 2021.

No medications or nutritional supplements were allowed prior to the study day.

Participant milestones

Participant milestones
Measure	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. Paracetamol: 1 g oral paractamol 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.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=12 Participants 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. Paracetamol: 1 g oral paractamol 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Finland	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: All healthy volunteers in this group.

Outcome measures

Outcome measures
Measure	Cmax n=12 Participants Comparison of the geometric mean values of the maximum capillary paracetamol concentrations (Cmax) measured with the electrochemical method and the mass-spectrometry (control). Data are presented as ratio-to-control.	AUC 0-last n=12 Participants Comparison of the geometric means of the area- under-the-curve (AUC) from timepoints 0-last measured with the electrochemical method and the mass-spectrometry (control). Data are presented as ratio-to-control.
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.	1.03 ratio-to-control Geometric Coefficient of Variation 21	1.17 ratio-to-control Geometric Coefficient of Variation 29

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cmax n=12 Participants Comparison of the geometric mean values of the maximum capillary paracetamol concentrations (Cmax) measured with the electrochemical method and the mass-spectrometry (control). Data are presented as ratio-to-control.	AUC 0-last n=12 Participants Comparison of the geometric means of the area- under-the-curve (AUC) from timepoints 0-last measured with the electrochemical method and the mass-spectrometry (control). Data are presented as ratio-to-control.
Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol in Capillary With Venous Plasma (Control), Both Measured by Mass-spectrometry.	1.50 ratio-to-control Geometric Coefficient of Variation 31	1.08 ratio-to-control Geometric Coefficient of Variation 30

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Johanna Kujala

Helsinki and Uusimaa Hospital District, Pain clinic

Phone: +358400780411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place