This is a healthy volunteer trial. The intended indication for the product is to investigate if upregulation of the tPA-gene by valproic acid results in increased tPA-release from endothelium in forearm. MedDRA version: 9.1 Level: LLT Classification code 10016603 Term: Fibrinolysis
Conditions
Interventions
Trade Name: Ergenyl Retard
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: VALPROIC ACID
CAS Number: 99661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Västra Götalandsregionen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Young and healthy voluntary men, aged 18-40 years. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Female sex 2) Smokers 3) Epilepsia 4) Hypertension 5) Malignant disease 6) Diabetes mellitus 7) BMI (body mass index) > 27 kg/m2 8) Cardiovascular disease 9) Any acute or chronic illness 10) Impaired renal or hepatic function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if upregulation of tPA-gene by valproic acid results in increased tPA-release from endothelium in forearm. ;Secondary Objective: To evaluate ischaemia test as a method for measuring endothelial function in terms of vasodilatation and tPA-release.;Primary end point(s): T-PA release from the forearm vascular endothelium validated as release pattern (ANOVA), total t-PA release (area under the curve), peak t-PA release and time-to-peak t-PA release. | — |
Countries
Sweden
Outcome results
None listed