Status:
COMPLETED
SIMOX - Induction of Oxidative Stress
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Klinisk Biokemisk Afdeling
Klinisk farmakologisk Afdeling
Conditions:
Oxidative Stress
Eligibility:
MALE
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to investigate if use of simvastatin is associated with the level of oxidative stress in humans. The association is examined by comparing changes in oxidative stress in a g...
Eligibility Criteria
Inclusion
- Caucasian
- healthy men
- 18-50 years
- BMI: 18-30
Exclusion
- Total cholesterol less than 3 mmol/L
- Use of natural and herbal medicines that is affected/affects simvastatin:
- anion exchangers, amiodarone, amlodipine, ciclosporin, clarithromycin, colchicine, danazol, diltiazem, erythromycin, fibrates, fluconazole, fusidin acid, grape fruit juice, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, niacin, posaconazole, rifampicin, telithromycin, verapamil, vitamin K-antagonists, voriconazole
- following diseases: a Coronary vascular disease b Renal insufficiency c Hepatic insufficiency d heart failure e Previous heart arrythmia f Hypokalaemia g Low blood pressure h hyperthyroidism i muscular toxicity j galactose intolerants k Lapp Lactase deficiency l Glucose/galactose-malabsorption m Psychiatric disorder
- allergies towards any of the tested medicine
- intake of narcotics within 2 months prior to trial
- intake of supplements within 2 months prior to trial
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02256254
Start Date
September 1 2014
End Date
February 1 2015
Last Update
March 10 2015
Active Locations (1)
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1
Department of Clinical Pharmacology
Copenhagen, Denmark, 2100