This is a healthy volunteer trial. Indications of the IMP's in the context of this trial are: Elevated risk on cardiovascular event Rheumatoid arthritis
Conditions
Interventions
Trade Name: Naproxen Pch Tablet 500mg
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Ibuprofen Pch Tablet 600mg
Ph
Sponsors
Medisch Spectrum Twente
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Use of medicins of any kind (also alternative medicins) except for oral contraceptives - Allergy to acetylsalicylic acid and / or NSAID’s - History of stomach ulcer(s) or stomach bleeding - History of stroke - Cardiovascular disease - Renal insufficiency - Thrombocytose - Thrombopenia - Aenemia - Von Willebrand’s disease - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure the pharmacodynamic interaction between naproxen + acetylsalicylic acid as compared to the placebo + acetylsalicylic interaction. ;Secondary Objective: To measure the pharmacodynamic interaction between: ibuprofen + acetylsalicylic acid diclofenac + acetylsalicylic acid meloxicam + acetylsalicylic acid All as compared to placebo + acetylsalicylic acid ;Primary end point(s): Primary endpoint is difference in closure time (sec) as a measure of platelet aggregation. The difference calculated, is closure time of the addition of an NSAID to acetylsalicylic acid, versus closure time of acetylsalicylic acid and placebo within one subject. | — |
Countries
Netherlands
Outcome results
None listed