Paracetamol for Healthy volunteers

Inclusion criteria

• {"criterion_text":"- Age: 18-30\n- Participants who are overtly healthy as determined by self-report and blood tests\n- Weight: Body weight within 45 – 120 kg and Body Mass Index within the range 18.5 – 30 kg/m2\n- Contraceptives: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n- Informed Consent: Capable of giving signed informed consent as described in Appendix 1. which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n- Language: Able to communicate fluently in Norwegian, as this will be the language in which study material, including the ICF is written in."}

Exclusion criteria

• {"criterion_text":"- Allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6, package insert).\n- Chronic pain condition\n- Currently being evaluated for, or undergoing treatment for medical/physical, psychological condition(s) or neuropsychiatric diagnoses\n- Acute inflammation of the liver (hepatitis)\n- Previous or current liver injury or kidney injury\n- Pregnancy\n- BMI ≤18.5 kg/m2 or BMI>30"}

Primary endpoints

• {"endpoint_text":"- •\tSelf-reported negative affect as measured with PANAS over the intervention period.","definition_or_measurement_approach":"Self-reported negative affect measured with the PANAS (Positive and Negative Affect Schedule) over the intervention period."}

Secondary endpoints

• {"endpoint_text":"- To assess whether paracetamol affects neurophysiological functioning in general and specifically related to emotion processing and stress, and if paracetamol affects anxiety, stress, depression and insomnia symptoms over the study period.","definition_or_measurement_approach":"Overall assessment of neurophysiological functioning and symptom measures over the study period (as described in protocol)."}
• {"endpoint_text":"- •\tSelf-reported positive affect as measured with PANAS over the intervention period.","definition_or_measurement_approach":"Self-reported positive affect measured with the PANAS over the intervention period."}
• {"endpoint_text":"- Anxiety score (BAI-II) measured on the 7th day","definition_or_measurement_approach":"Beck Anxiety Inventory (BAI-II) score measurement on day 7."}
• {"endpoint_text":"- Depression score (BDI-II) measured on the 7th day","definition_or_measurement_approach":"Beck Depression Inventory II (BDI-II) score measurement on day 7."}
• {"endpoint_text":"- Perceived stress scale (PSS score) measured on the 7th day","definition_or_measurement_approach":"Perceived Stress Scale (PSS) score measurement on day 7."}
• {"endpoint_text":"- Sleep, measured by Pittsburg Sleep Scale (PSQ-I score) on the 7th day","definition_or_measurement_approach":"Pittsburgh Sleep Quality Index (PSQI) score measurement on day 7."}
• {"endpoint_text":"- EEG: LPP response to emotional stimuli measured in the Emotional Interrupt Task","definition_or_measurement_approach":"Electroencephalography measurement of Late Positive Potential (LPP) response during the Emotional Interrupt Task."}
• {"endpoint_text":"- EEG: Resting state EEG dynamics Self-reported and evoked physiological stress response in the Montreal Imaging Stress Task (MIST).","definition_or_measurement_approach":"Resting-state EEG dynamics and physiological stress responses measured during the Montreal Imaging Stress Task (MIST)."}
• {"endpoint_text":"- Biomarkers: Change of IL-6 and IL-8 during intervention period.","definition_or_measurement_approach":"Measurement of inflammatory biomarkers IL-6 and IL-8 changes over the intervention period."}

Norway

Earliest CTIS Part Ii Submission Date

09-01-2026

Latest Decision Or Authorization Date

27-01-2026

Processing Time Days

18

Number Of Sites

1

Number Of Participants

84

Primary sponsor

Full Name

Oslo Metropolitan University

Organisation Type

Educational Institution

Country Of Registered Address

Norway

Third parties

• {"country":"Norway","full_name":"Ministry of Education and Research, Norway","duties_or_roles":"Monetary support / Funder","organisation_type":""}
• {"country":"Norway","full_name":"Johanne og Einar Eilertsens forskningsfond til sønnen Johan Eilertsens minne","duties_or_roles":"Monetary support / Funder","organisation_type":""}