The objective of the present study is to study paracetamol effects on social pain and empathy under standardized international conditions (ICH-GCP) for planning, conduction and reporting of clinical pharmaceutical studies in humans. The study included MRI imaging of brain activity, analysis of genomic biomarkers potentially explaining interindividual variation. It is controversial whether the effects are of immediate nature or develop during a period of about 10 days. Therefore, the study is separated into two study phases. Single dosing (SD) is applied in study phase 1 and multiple-dosing (MD) in study phase 2. The study compares paracetamol with placebo and in the study phase 1 also with ibuprofen as analgetically active control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
150
Paracetamol oral tablet
Ibuprofen oral tablet
Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, Germany
RECRUITINGEffect of paracetamol and ibuprofen on social pain and empathy
Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale.
Time frame: 8 hours
Effect of paracetamol on social pain and empathy
Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale.
Time frame: 14 days
Psychological effects of paracetamol and ibuprofen
Interindividual variation of analgesic effects measured using fMRI. MRI will be performed to reflect differences in brain activation by Psychometric test.
Time frame: 8 hours
Pharmacokinetics effects of paracetamol and ibuprofen
Blood samples for determination of study drug concentrations in plasma will be taken at different time-point. This will be used to calculate Maximum Plasma Concentration (Cmax).
Time frame: 8 hours
Pharmacogenes roles in paracetamol and ibuprofen metabolism
Genetic analysis of relevant genes responsible for paracetamol and ibuprofen Absorption, Distribution, Metabolism and Excretion (ADME).Healthy volunteers will provide a blood sample for molecular genetic analyses of the various candidate genes, e.g. drug transporters and metabolizing enzymes. This will shed light on the interindividual variation of analgesic effects.
Time frame: 8 hours
Psychological effects of paracetamol
Interindividual variation of analgesic effects measured using fMRI. MRI will be performed to reflect differences in brain activation by Psychometric test.
Time frame: 14 days
Pharmacokinetics effects of paracetamol
Blood samples for determination of study drug concentrations in plasma will be taken at different time-point. This will be used to calculate Maximum Plasma Concentration (Cmax).
Time frame: 14 days
Pharmacogenes roles in paracetamol metabolism
Genetic analysis of relevant genes responsible for paracetamol Absorption, Distribution, Metabolism and Excretion (ADME). Healthy volunteers will provide a blood sample for molecular genetic analyses of the various candidate genes, e.g. drug transporters and metabolizing enzymes. This will shed light on the interindividual variation of analgesic effects.
Time frame: 14 days
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