Drug MechanismNCT04690673
Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique
A study testing Paracetamol and Paracetamol concentration measurements and lipidomic assessment in people with Drug Mechanism and Healthy, run by Johanna Kujala at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Mechanism, Healthy
- What is being tested?
- Paracetamol and Paracetamol concentration measurements and lipidomic assessment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- 15 Jan 2021to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, no medication of any kind.
- Age 18-45
- BMI 18.5 - 30
- Informed consent
Who cannot join
- Pregnancy, lactation.
- prisoner
- smoking
- less than 3 months from prior blood donation or clinical pharmacological study
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Paracetamol, Paracetamol concentration measurements and lipidomic assessment
- Keywords
- electrochemical, Paracetamol, Lipidomics, Endocannabinoid system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
1 g oral paractamol
Paracetamol concentration measurements and lipidomic assessmentDiagnostic 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 | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Paracetamol; Diagnostic Test: Paracetamol concentration measurements and lipidomic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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).
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start15 Jan 2021
- Primary completion31 Mar 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug MechanismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Healthy volunteers
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johanna Kujala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johanna Kujala, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690673
- Sponsor's protocol ID
- FEPODPara2020-1
- Status last verified
- Jan 2025
- First submitted
- 14 Dec 2020
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04690673
- Acronym / sponsor ID
- FEPODPara2020-1
- Conditions
- Drug Mechanism, Healthy
- Keywords
- electrochemical, Paracetamol, Lipidomics, Endocannabinoid system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johanna KujalaUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Paracetamol, Diagnostic Test: Paracetamol concentration measurements and lipidomic assessmentAll healthy volunteers are in this group. They receive 1g paracetamol orally. Saline-, urine-, venous blood and fingerprick samples will be collected at timely intervals. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, no medication of any kind.
- Age 18-45
- BMI 18.5 - 30
- Informed consent
Key exclusion criteria (4 listed)
- Pregnancy, lactation.
- prisoner
- smoking
- less than 3 months from prior blood donation or clinical pharmacological study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol1 g oral paractamol | Drug | Study group |
| Paracetamol concentration measurements and lipidomic assessmentParacetamol concentration is measured from saline-, urine-, venous blood- and fingerprick- samples at timely intervals. Also serum lipidomic assessment is performed from venous blood samples. | Diagnostic test | Study group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Drug Mechanism
Active, not recruitingPhase 3
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Neuromuscular Agents, Peripheral Nervous System Agents
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Innate Immunity, Mucosal Immunity
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol and Paracetamol concentration measurements and lipidomic assessment in people with Drug Mechanism and Healthy, run by Johanna Kujala at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.