A study on healthy volunteers investigating if simvastatin affects the body ability to reduce stress from oxygen (oxidative stress)

Phase 1

• Conditions: Simvasatins effect on Oxidative Stress; MedDRA version: 17.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-000959-92-DK
• Lead Sponsor: Department of Clinical Pharmacology Q

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-10
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified