Simvasatins effect on Oxidative Stress MedDRA version: 17.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Simvastatin 'KRKA'
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Other descriptive name: SIMVASTATIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Department of Clinical Pharmacology Q
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inc-1: caucasian Inc-2: healthy male Inc-3: between 18 and 50 of age Inc-4: BMI between 18 and 30kg/m2 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Ex-1: Total cholesterol less than 3 mmol/L Ex-2: Use of natural and herbal medicines that is affected/affects simvastatin: anionbyttere, amiodaron, amlodipin, ciclosporin, clarithromycin, colchin, danazol, diltiazem, erythromycin, fibrater, fluconazol, fusidine acid, grape fruitjuice, HIV protease inhibotors, itraconazol, ketoconazol, nefazodon, nicotinsyre (niacin), posaconazol, rifampicin, telithromycin, verpamil, vitamin K-antagonists, voriconazol Ex-3 following diseases: a Coronary vascular disease b Renal insufficiency c Hepatic insufficiency d heart failure e Previous heart arytmia f Hypokalimia g Low blood preassure h hyperthyroidisme i muscular toxicity j galactose intolerens k Lapp LActase deficiency l Glucose/galactose-malabsorption m Psykiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The scope of the trial is to investigate if simvastatim affecr oxidative stress in helathy volunteers. This will be measured by the biomarkers 8-oxoGuo and 8-oxodG in urine before and after treatment with simvastatin. ;Secondary Objective: Biomarkers malone dialdehyde, vitamine C, vitamine E and Biopterine is measured in plasma before and after treatment. This is compaired with placebo treatment.;Primary end point(s): The effect on oxidative stress will be established by comparing the excretion of the biomarkers 8-oxoGuo and 8-oxodG before and after treatment with simvastatin. The result will be compared with the results from the placebo treatment.;Timepoint(s) of evaluation of this end point: Evaluation will e after last patient last visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The effect on oxidative stress will be established by comparing the excretion of the biomarkers Malone dialdehyde (MDA), Vitamine C (Vit-C), Vitamine E (Vit-E) and Biopterine (BH, as BH4 and BH2) before and after treatment with simvastatin. The result will be compared with the results from the placebo treatment. MDA: the secondary object is a significant decrease of MDA in plasma after treatment with simvastatin compared to placebo Vit-C: the secondary object is a significant increase of vitamine C in plasma after treatment with simvastatin compared to placebo Vit-E: the secondary object is a significant increase of vitamine E in plasma after treatment with simvastatin compared to placebo BH: the secondary object is a significant increase of BH-4 in plasma after treatment with simvastatin compared to placebo and an increase in BH-4/BH-2 ratio;Timepoint(s) of evaluation of this end point: Evaluation will be after last volunteers last visit | — |
Countries
Denmark
Contacts
Public ContactSponsor
Department of Clinical Pharmacology Q
Outcome results
None listed